DOH GUIDELINES for LEPTOSPIROSIS for HOSPITALS
2019 Edition
DOH GUIDELINES for
LEPTOSPIROSIS for HOSPITALS 2019 Edition
DOH Guidelines for Leptospirosis for Hospitals
i DOH Guidelines for Leptospirosis for Hospitals
F O R E W O R D
ii DOH Guidelines for Leptospirosis for Hospitals
iii DOH Guidelines for Leptospirosis for Hospitals
TECHNICAL WORKING GROUP
Research Institute for Tropical Medicine Celia C. Carlos, MD Arthur Dessi E. Roman, MD
National Kidney and Transplant Institute Romina A. Danguilan, MD Mel-Hatra I. Arakama, MD
CONTRIBUTORS Amang Rodriguez Memorial Medical Center Imelda M. Mateo, MD Dr.Jose Fabella Memorial Hospital Esmeraldo T. Ilem, MD East Avenue Medical Center Alfonso G. Nuñez III, MD Jose R. Reyes Memorial Medical Center Emmanuel F. Montaña Jr., MD National Center for Mental Health Alan Baquir, MD National Children’s Hospital Epifania S. Simbul, MD National Kidney and Transplant Institute Rose Marie R. Liquete, MD Joselito R. Chavez, MD Philippine Orthopedic Center Jose Brittanio S. Pujalte Jr., MD Quirino Memorial Medical Center Evelyn Victoria E. Reside, MD Rizal Medical Center Relito M. Saquilayan, MD San Lazaro Hospital Edmundo B. Lopez, MD Benjamin D. Estrella Jr., MD Rontgene M. Solante, MD Tondo Medical Center Maria Isabelita M. Estrella, MD Dr. Jose N. Rodriguez Memorial Hospital Alfonso Victorino H. Famaran, MD Las Piñas General Hospital and Rodrigo H. Hao, MD Satellite Trauma Center San Lorenzo Ruiz Women’s Hospital Marilou T. Nery, MD Valenzuela Medical Center Maria Estrella B. Litam, MD DOH-TRC Bicutan Alfonso A. Villaroman, MD DOH-NCR Corazon I. Flores, MD Ma. Paz P. Corrales, MD DOH-FICT NCR Emmanuel A. Tiongson, MD Ruben C. Flores, MD Francisco A. Valdez, MD
A Project of FICT Team NCR in cooperation with NKTI under the supervision of Asec. Elmer G. Punzalan.
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iv DOH Guidelines for Leptospirosis for Hospitals
TABLE OF CONTENTS
Chapter 1: MANAGEMENT PROTOCOL FOR LEPTOSPIROSIS
I. Introduction 1
II. Criteria for Diagnosis 5
III. Indications for Admission and Guidelines on Site-of-Care Decisions 5
IV. Laboratory Work Up Leptospiral Tests 7 Non-Leptospiral Tests 8
V. General Guidelines in the Management of Leptospirosis 9
VI. Antibiotic Management 9
VII. Steroid Therapy 11
VIII. Pulmonary Complications of Leptospirosis Diagnosis of Pulmonary Complications of Leptospirosis 11 Management of Pulmonary Complications of Leptospirosis 12 Extracorporeal Membrane Oxygenation in leptospirosis 15
IX. Renal Complications of Leptospirosis 15
X. Prevention and Control 18
XI. Chemoprophylaxis Pre-exposure Prophylaxis 18 Post-exposure Prophylaxis 19
XII. References 20
Appendices Appendix A. Modified Faine’s Criteria (2012) 21 Appendix B. Guidelines in Specimen Collection, Storage, Transport and Submission 22
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Chapter 2: UPSURGE POLICIES AND PROCEDURES
I. Statement of Purpose and Scope Purpose 25 Scope 25
II. Key Policies Criteria for Activation of Leptospirosis Emergency Policy 25 Person Responsible for Activation of the Leptospirosis Upsurge Policy 26 During Office Hours 26 After Office Hours 27 Activation of the Leptospirosis Upsurge Management Team 27 Critical Bed Status Procedure 28 Standards for Admission of Leptospirosis Patients 28
III. Roles and Responsibilities of the Various Departments/ Divisions/Sections in the Management of a Leptospirosis Upsurge Emergency Room 29 Division of Internal Medicine 30 Divisions of Adult and Pediatric Nephrology 31 HEMB Team 32 Division of Organ Transplantation and Vascular Surgery 32 Department of Pathology and Laboratory Medicine 32 Section of Pulmonary Medicine 32 Department of Medical Imaging and Therapeutic Radiology 32 Nursing Services 33 Hemodialysis Unit 33 Peritoneal Dialysis Unit 34 Infection Prevention and Control Committee 35 Medical Social Services Division 35 Pharmacy Division 35 Housekeeping Section 36 Procurement and Supply Management Divisions 36 Central Supply and Sterilization Unit 37 Billing and Claims Division 37 Admitting and Discharge Section 37 Information Resource Management Division 38 Nutrition and Dietetics Division 38
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IV. Setting up a Leptospirosis Ward 39
V. Staffing Requirements in the Leptospirosis Ward Medical Staffing 40 Nurses Staffing 41
VI. Health Care Provider Network 42
VII. Antibiotic Prophylaxis for Leptospirosis For Adults 43 For Pregnant Women 43 For Children 43
Appendices Appendix A. Treatment Algorithm for Leptospirosis 45 Appendix B. Leptospirosis Prophylaxis Survey 47 Appendix C. Treatment Algorithm for Leptospirosis (Pediatric Patients) 48 Appendix D. Leptospirosis Census Format for Reporting 51 Appendix E. Criteria for Assisted Ventilation for Leptospirosis Patients 52
vi DOH Guidelines for Leptospirosis for Hospitals
Chapter 1: MANAGEMENT PROTOCOL FOR LEPTOSPIROSIS
I. INTRODUCTION
Leptospirosis is a zoonotic infection caused by pathogenic spirochetes of the genus Leptospira. Ten (10) out of the 22 identified species under this genus are considered pathogenic, while the remaining 7 and 5 are non-pathogenic, free-living saprophytes (e.g. Leptospira biflexa) or of unclear pathogenicity, respectively.1 An older system has been used to classify them into serovars (based on serology) so isolates are currently identified using two systems, e.g. Leptospira icterohemorrhagiae serovar manilae. Over 250 serotypes of pathogenic leptospires have been recognized and the severe form of leptospirosis have been reported to be caused by all of these.2 Leptospira icterohaemorrhagiae, by far, has been commonly associated with severe disease. In the Philippines, earlier studies reported that the major serovars affecting humans in Metro Manila and neighboring provinces were Manilae, Losbanos, Tarassovi, and Poi.3
In Philippines, leptospirosis tends to occur frequently in urban flood-prone areas such as Metro Manila. This disease gained much attention after an outbreak following typhoon Ondoy in October of 2009. About two weeks following this heavy rainfall typhoon that left many areas of Metro Manila flooded, the Department of Health reported 2,894 probable and confirmed cases of leptospirosis with 210 deaths.4
From January 1, 2018 to December 31, 2018, a total of 5,232 cases were reported to the Department of Health with a case fatality rate of 9.65%. This is a 71% increase in the total number of cases compared to 2017.5 In fact, in July of 2018, the Department of Health has declared an outbreak of leptospirosis in certain areas of Metro Manila. Outbreaks of leptospirosis in the Philippines are expected to occur with increasing incidents of heavy rainfall, rapid urbanization (dramatic increase in populations), deforestation, increasing number of flood-prone areas, poor infrastructures, among many other factors.
Leptospirosis is primarily a disease of domesticated and wild animals. Humans are infected through direct and indirect contact with these animals. The source of infection is water or soil contaminated with infected urine, infected urine or tissues from infected animals. The leptospires enter through cuts and abrasions in the skin or mucosal surfaces, the conjunctiva, or by inhalation (into the lungs) of droplets or aerosols of fluid containing leptospires. After penetrating intact mucous membranes or abraded skin, leptospires enter the blood stream and are rapidly carried to all
1 DOH Guidelines for Leptospirosis for Hospitals parts of the body (including the cerebrospinal fluid [CSF] and the eyes) presenting as an acute, systemic disease is characterized by extensive vasculitis.
The incubation generally is 5-14 days but a range of 2 to 30 days has been noted. The incubation period does not vary significantly among serotypes. It may present as influenza-like illness with headache and myalgia in its mild form and may present with jaundice, renal dysfunction and hemorrhage (Weil’s Syndrome) when it presents as severe form.
Leptospirosis presents in two (2) forms: anicteric (mild) or icteric (severe) leptospirosis. Anicteric (mild) leptospirosis is often characterized by abrupt onset of fever, headache, severe muscle aches, malaise and prostration. High intermittent fever, chills, persistent headache, severe myalgias, abdominal pain and nausea and vomiting persist for 4-7 days. Death almost NEVER occurs during this stage. In anicteric infections, the second stage may not occur. On the other hand, icteric (severe) leptospirosis or Weil Syndrome may present with impaired renal and hepatic function, hemorrhage, vascular collapse, and even severe alterations in consciousness. This form has a high mortality rate.
The clinical course of leptospirosis varies but it is generally predictable. Both forms of leptospirosis follow a biphasic course: 1. The LEPTOSPIREMIC PHASE (or ACUTE stage) is characterized by an acute systemic infection. The onset of symptoms is abrupt and resolves after 4-7 days. Symptomatic improvement and lysis of the fever coincide with the disappearance of leptospires from the blood, cerebrospinal fluid and all other tissue with the EXCEPTION of the aqueous humor (resolves in 4-30 days) and renal parenchyma (persists for 1-4 weeks in the urine). Antibody titers to leptospires develop rapidly. This immune response heralds the second or immune stage of the illness.
2. The IMMUNE PHASE (sometimes LEPTOSPIRURIC PHASE, CONVALESCENT STAGE) is the second stage and lasts 4-30 days. Occasionally, there is a brief asymptomatic period of 2-3 days between the two stages. Leptospiruria continues for 1 week to 1 month. Generally, this phase is not affected by antibiotic therapy. This phase is characterized by the presence of circulating antibody and development of meningitis, uveitis, rash, and (in severe cases) hepatic and renal involvement. In icteric cases, leptospires can sometimes be isolated from the blood for 24-48 hours after the appearance of jaundice.1
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In the Philippines, majority of the symptoms of Leptospirosis is non-specific, which indicates that the initial impression could be viral rather than bacterial. Table 1 lists down the percentage frequencies of signs and symptoms of leptospirosis seen in our local setting. A comparison of two studies from the Philippine 2009 outbreak reported that the most common clinical features include fever, myalgia, conjunctival suffusion, malaise, headache, abdominal pain, oliguria, and jaundice.
Table 1. Clinical Features of Leptospirosis after a flood, National Capital Region, 2009 Sign or Symptom 9 Manila Hospitals, 20096 San Lazaro Hospital, 20097 Number of patients 259 confirmed leptospirosis cases 471 cases Fever 98.5 100* Myalgia/calf-tenderness 78.1 76.7 Malaise 74.9 44.2 Headache 55.6 52.2 Chills 44.8 NR Conjunctival suffusion 59.3 78.1 Hypotension 23.6 NR Abdominal pain 52.7 61.2 Nausea/vomiting 52.0 57.8 Diarrhea 39.0 40.8 Jaundice 38.0 47.8 GI bleeding 16.1 NR Oliguria 56.6 60.7 Hematuria 22.3 33.1 Cough 30.5 17.6 Dyspnea 21.6 NR Crackles/rales 23.3 NR Hemoptysis 14.9 3.2 Hemorrhagic signs 14.6 0.4 *part of inclusion criteria; NR – no report
These clinical findings are consistent with prior local studies done in Metro Manila since the 1970s (Table 2).
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8
outbreak the with 2009 Manila Metro atcompared in various admitted calleptospirosis hospitals seasonal of features
Table Clini 2.
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II. CRITERIA FOR DIAGNOSIS
Leptospirosis should be suspected in an individual with: An acute febrile illness of at least 2 days AND Two or more of the following symptoms: myalgia, calf tenderness, conjunctival suffusion, chills, abdominal pain, headache, jaundice, or oliguria AND Any risk factor for acquiring the disease which includes: - residing in a flooded area - wading or swimming in floods and contaminated water, with or without cuts or wounds - contact with animal fluids especially carcass - ingestion of contaminated water
A checklist for diagnosing leptospirosis for frontliners have been developed (See Appendix A). The checklist consists of three parts: Clinical data, Epidemiologic factors and Bacteriologic and laboratory findings. Using paired MAT as the gold standard, the estimated sensitivity and specificity of the WHO criteria were 33% and 66% respectively.9 Studies on the clinical utility of this criteria are were probably limited by the small sample size.
III. INDICATIONS FOR ADMISSION AND GUIDELINES ON SITE-OF-CARE DECISIONS
Patients with suspected leptospirosis presenting with MILD symptoms can be managed on an OUT-PATIENT SETTING. These include patients with stable vital signs, anicteric sclerae, no jaundice, with good urine output, no evidence of meningismus/ meningeal irritation, no dyspnea, no tachypnea, no hemoptysis, no bleeding, not in sepsis / septic shock, and can take oral medications.
On the other hand, patients with suspected MODERATE to SEVERE LEPTOSPIROSIS should be admitted in a healthcare facility for proper diagnosis and appropriate monitoring and management. The presence of the following signs and symptoms will classify a patient to have moderate to severe leptospirosis and will require admission: Unstable vital signs Jaundice / Icteric sclerae Abdominal pain Nausea, vomiting and diarrhea
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Oliguria or anuria Bleeding Meningismus / meningeal irritation Sepsis / septic shock Altered mental status Difficulty of breathing or hemoptysis
Patients with leptospirosis who are suspected to have pulmonary complications such as pulmonary hemorrhage or acute respiratory distress syndrome (ARDS) require special attention because these conditions have been consistently associated with increased mortality. These patients present with dyspnea, tachypnea, chest x-ray findings of localized or multilobar infiltrates or pleural effusion. The decision to admit a leptospirosis patient with pulmonary complications will depend on the level of hypoxemia (see Table 6).
Moderate hypoxemia: 100 Patients with moderate to severe hypoxemia need to be admitted to the INTENSIVE CARE UNIT for closer monitoring and/or invasive ventilation. Patients with mild hypoxemia may be admitted in a step down unit or monitored closely in the wards. IV. LABORATORY WORK UP Given the generally low sensitivity and long turnaround times of diagnostics for leptospirosis, it is not necessary to confirm the diagnosis or wait for the result of these tests before initiating treatment. Clinical diagnosis especially in the context of an epidemiologic risk factor and a high index of suspicion are more important. Early recognition and treatment are important to prevent complications of the severe disease and mortality. However, if definitive or confirmatory diagnosis is warranted in suspected cases and for epidemiological and public health reasons, these are the locally available diagnostic tests for leptospirosis. The DEFINITIVE diagnosis depends on laboratory findings. Criteria for definite diagnosis of leptospirosis are either: Isolation of the leptospires from the patient’s body fluid or tissue OR Seroconversion or a rise in antibody titer in the microscopic agglutination test (MAT) in the presence of compatible clinical illness 6 DOH Guidelines for Leptospirosis for Hospitals PRESUMPTIVE diagnosis of Leptospirosis may be based on the following findings: positive dark field examination; presentation of clinical symptoms that are compatible with leptospirosis and a microscopic agglutination titer of 1:100 or greater; a positive macroscopic agglutination slide test reaction on a single specimen obtained after the onset of symptoms; and stable microscopic agglutination titer of 1:100 or greater in two or more serum specimens obtained after the onset of symptoms A. LEPTOSPIRAL TESTS 1. Microbiologic Test: Culture Method (definitive) Culture of leptospires can be done using blood or cerebrospinal fluid (CSF) obtained during the septicemic stage of illness or urine during the immune and convalescent stage. Additionally, tissue sections obtained by biopsy or at necropsy, can be submitted for culture of Leptospira. The media used for culture are Fletcher semisolid medium or Ellinghausen-McCullough - Johnson-Harris (EMJH) semisolid medium or Tween 80 - albumin medium (OAC) or Korthoff medium. Cultures are incubated at 28-30oC in the dark for 6 weeks or longer. 2. Microbiologic Test: Non-culture Method a. Dark field microscopy – recommended as an aid that may suggest BUT NOT establish the diagnosis of Leptospirosis b. PCR for detection of leptospiral nucleic acid in blood or urine (definitive) 3. Serologic Tests a. Microscopic Agglutination Test (MAT) – detects agglutinating antibodies against live leptospires using darkfield microscopy. The 21-serovar MAT is considered the "reference standard" or cornerstone of serodiagnosis of leptospirosis. However, a genus-specific MAT using a non- pathogenic Leptospira patoc I strain are being performed by some centers. Interpretation: Single specimen: Titer > 1:800 (probable) Paired specimen (using acute and convalescent sera): four-fold increase (definitive) 7 DOH Guidelines for Leptospirosis for Hospitals b. Rapid leptospiral diagnostic kits (i.e. immunochromatographic tests or ICTs) - useful rapid tests in the early diagnosis of leptospirosis among patients with compatible signs and symptoms. There is an increasing number of tertiary healthcare facilities that are offering these rapid tests already. c. IgM ELISA- simple, with acceptable sensitivity that is quite variable depending on the method of ELISA performed Table 3. Appropriate timing of Specimen collection for specific leptospiral tests Timing 0-7 days 7-14 days 14-28 days (from onset of illness) Specimen and leptospiral CSF for culture or darkfield test microscopy Dialysate for leptospiral culture Heparinized blood for culture and or PCR Serum (acute specimen) Serum for serologic tests (rapid ICTs, IgM for MAT ELISA) and MAT (convalescent specimen) Urine for culture Refer to Annex B: Guidelines on Specimen collection, storage and transport for leptospiral tests. B. NON-LEPTOSPIRA TEST a. MILD 1. CBC with quantitative platelet count 2. Urinalysis 3. BUN and Creatinine 4. Liver function tests (SGPT, SGOT) b. MODERATE to SEVERE (request each test if clinically indicated) 1. Serum sodium and potassium 2. Bilirubins (Total Bilirubin, direct and indirect bilirubin) 3. PT/PTT 4. Total protein with A/G, Alkaline phosphatase 5. Chest X-ray 6. 12-Lead ECG 7. Arterial blood gas (ABG) - severe metabolic acidosis (ph< 7.2, HCO3 <10) and hypoxemia (PaO2 < 60 mmHg, SaO2 < 90%, PF ratio <250) 8. Total CPK with fractionated CPK-MM determination 8 DOH Guidelines for Leptospirosis for Hospitals V. GENERAL GUIDELINES IN THE MANAGEMENT OF LEPTOSPIROSIS Most cases of leptospirosis will be mild and self-limited. A suspicion of leptospirosis should warrant management as such even without evidence from leptospiral diagnostics. Supportive management with hydration and analgesic/antipyretic therapy with paracetamol are recommended. Correct electrolyte derangements. Knowledge on the clinical indicators of progression from an undifferentiated fever to severe leptospiral disease is very limited. Thus, it is recommended that any illness [regardless of severity, duration or phase of the disease] that prompts a patient to seek medical consult and leptospirosis is suspected, antibiotic therapy should be administered to shorten the duration of illness and reduce shedding of organisms in the urine. When the disease is classified as severe, the management is generally the same as in the management of organ failure from sepsis. Supportive care with renal replacement therapy, ventilatory support, and blood products may be required. Consequently, timely referrals to specialists and facilities who can provide such services are also recommended to prevent delays and progression of anticipated complications. The subsequent chapters will discuss the specific recommendations in the various aspects of leptospirosis management. VI. ANTIBIOTIC MANAGEMENT All patients with suspected leptospirosis should be started on antimicrobial therapy regardless of the phase of the disease of duration of symptoms to shorten the duration of illness. While there is insufficient evidence on the use of antibiotics in preventing death from leptospirosis, its use has been shown to have beneficial effects on several clinically relevant and important outcomes (e.g. decreased the duration of clinical illness by 2-4 days).10 Treatment with effective antibiotics should be initiated as soon as the diagnosis of leptospirosis is suspected. Antibiotic administration should not be delayed regardless of the need for renal replacement therapy. Doxycycline 5 mg/kg/day PO in 2 divided doses (max 200mg/day) x 1 week. 9 DOH Guidelines for Leptospirosis for Hospitals Table 4. Recommended Antibiotic Regimens for Leptospirosis MILD LEPTOSPIROSIS ADULT CHILDREN Doxycycline 100 mg BID PO for 10 days Amoxicillin 30-50 mg/kg/day in 3 divided doses. Maximum of 2 grams per day First line First Amoxicillin 500mg QID or 1g q8h Azithromycin dihydrate 1 g initially, Erythromycin 10 mg/kg/day orally in four followed by 500 mg OD for 2 more divided doses for 1 week days Alternative SEVERE LEPTOSPIROSIS (WEIL SYNDROME) ADULT CHILDREN Penicillin G 1.5 million units IV q 6 Aqueous penicillin G 6-8 million U/m2/day hrs for 7 days in 6 divided doses for 1 week Ceftriaxone 1gm q24h for 7 days Ampicillin 100 mg/kg/day IV every 6 hours Primary Primary regimen Ampicillin 0.5-1.0 gm q6h Tetracycline 25-50 mg/kg/day orally in four Azithromycin dihydrate 500 mg OD divided doses or IV tetracycline 10- for 5 days 20mg/kg/day IV in four divided doses, max Cefotaxime 1 gm q6h 3 g/day, avoid in children < 9 years Doxycycline 5 mg/kg/day PO in 2 divided doses (max 200mg/day) x 1 week Ampicillin 100 mg/kg/day IV every 6 hours Alternative or Erythromycin 10 mg/kg/day orally in four divided doses for 1 week Note: Step-down therapy can be instituted once patient is clinically stable and able to tolerate oral medication. Any oral antibiotic can be selected. Table 5. Dosage of Antibiotics in Adults with Renal Impairment Antibiotic Dose for Adjustment for renal failure Normal Renal Function Estimated creatinine clearance (CrCl), ml/min 50-90 10-50 <10 Amoxicillin 500mg q6h or 1g q8h Q8h Q8-12h Q24h Ampicillin 0.5-1gm q6h Q6h Q6-12h Q12-24h Azithromycin 500 mg OD No dose adjustment Dehydrate Cefotaxime 1 gm q6h Q8-12h Q12-24h Q24h Ceftriaxone 1 gm q24h No dose adjustment Doxycycline 100mg BID No dose adjustment Penicillin G 1.5 MU q6h No dose adjustment Table adapted from: Collaborative Statement of the Philippine Society for Microbiology and Infectious Diseases, Philippine Society of Nephrology and the Philippine College of Chest Physicians Council on Critical Care and Pulmonary Vascular Diseases. (2010). The Philippine Clinical Practice Guidelines on the Diagnosis, Treatment and Prevention of Leptospirosis in Adults 2010. 10 DOH Guidelines for Leptospirosis for Hospitals VII. STEROID THERAPY Steroids have been reported to reduce or delay the need for ventilator support, improve PTT or mortality among patients with leptospirosis. While the evidence for its use is not overwhelming, steroid therapy has found relevance in clinical practice given the devastating complications of severe leptospirosis, particularly pulmonary hemorrhage. Thus, steroid therapy is suggested for: (1) patients at high-risk of pulmonary hemorrhage, and (2) AKI PLUS any of the following: platelet count <100 MAP <65 mmHg Prolonged PT/PTT Need for inotropes If there is a decision to use steroids for such patients, it should be initiated as soon as the first signs and symptoms of pulmonary leptospirosis is detected (e.g. tachypnea, hemoptysis, dyspnea). The following regimens have been used: a. Methylprednisolone at a dose of 500 mg IV/day for 3 days, with the first dose given as bolus within the first 12 hours of onset of respiratory involvement. b. For those with renal failure, methylprednisolone 500mg IV after HD OD x 3 days. After 3rd MP dose or after any episode of hemoptysis, give Cyclophosphamide 1g IV as a single dose after HD. VIII. PULMONARY COMPLICATIONS OF LEPTOSPIROSIS Pulmonary hemorrhage and Acute Respiratory Distress Syndrome (ARDS) are the two most common pulmonary complications of leptospirosis. They are usually associated with worse prognosis and high mortality. A. Diagnosis of pulmonary complications of leptospirosis Pulmonary symptoms usually appear between the 4th and 6th day of disease. Significant risk factors for pulmonary complications are delayed antibiotic treatment and thrombocytopenia at the onset of the disease. Pulmonary involvement should be suspected in a leptospirosis patient with the following: Tachypnea (RR > 30 breaths/minue) Hemoptysis Cough Dyspnea 11 DOH Guidelines for Leptospirosis for Hospitals On top of the clinical factors, findings from important laboratory tests aid in the diagnosis of ARDS. The severity of pulmonary involvement can be assessed by abnormalities on chest radiograph and arterial blood gas. 1. Radiographic findings commonly accompany pulmonary symptoms. All patients have bilateral pulmonary infiltration and maybe seen as early as the first 24 hours of the systemic stage of leptospirosis. 2. Hypoxemia and hypocarbia are common blood gas abnormalities. Elevated PCO2 is seen in severe cases. Continuous monitoring of oxygen saturation is recommended in the presence of pulmonary complications. The table below are parameters that can be used for the diagnosis of ARDS and for risk stratification to identify site-of-care, particularly the level of oxygenation. Table 6. American-European Consensus Conference Criteria for ARDS11 Timing Within 1 week of a known clinical insult or new/worsening respiratory symptoms Origin of Edema Respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present Mild Moderate Severe Oxygenation 200 B. Management of pulmonary complications of leptospirosis Initiate steroid therapy as soon as pulmonary involvement is recognized Initiate either invasive (mechanical ventilation) or noninvasive ventilation (bipap) if there are bilateral infiltrates on chest radiograph and PaO2/FiO2 is <300 or SaO2 is less than 90% (Refer to Figure 1). Referral to a pulmonologist is recommended. 12 DOH Guidelines for Leptospirosis for Hospitals Figure 1. Algorithm for the Diagnosis and Management of Leptospirosis with Pulmonary Complications 13 DOH Guidelines for Leptospirosis for Hospitals Non-invasive ventilation (NIV) vs. Invasive ventilation A trial of NIV can be done in most patients who do not require emergent intubation. The presence of the following conditions, however, are contrainidication to NIV and therefore warrant invasive ventilation: Table 7. Contraindications To Non-Invasive Positive Pressure Ventilation12 Non-respiratory organ failure that is acutely life-threatening Severe encephalopathy (eg, GCS <10) Severe upper gastrointestinal bleeding Hemodynamic instability or unstable cardiac arrhythmia Facial or neurological surgery, trauma, or deformity Upper airway obstruction Inability to cooperate/protect airway Inability to clear secretions High risk for aspiration Table adapted from: International Consensus Conferences in Intensive Care Medicine: Noninvasive positive pressure ventilation in acute respiratory failure. Am J Respir Crit Care Med 2001; 163:283. Recommended initial non-invasive ventilator setting are as follow: inspiratory positive airway pressure (IPAP) of 10cmH20, and expiratory positive airway pressure (EPAP) of 4-5cmH20 = Pressure support level 5 – 6 cmH20. Target tidal volume of 6-8 mls/Kg (ideal body weight) is aimed for all adult patient. Optimal noninvasive positive pressure ventilation (NPPV) is the lowest pressure and lowest Fio2 that achieved SaO2 of 90% or PaO2 of 60mmHg without further clinical deterioration. Recommended initial mechanical ventilator settings are as follows: assist/control mode, utilizing low tidal volume at 6ml/kg body weight, positive end expiratory pressure (PEEP) of 5cmH2O, FiO2 of 100% and respiratory rate of 25/min. FiO2 and PEEP should be adjusted accordingly to maintain SaO2 ≥90%. If there are facilities available to measure plateau pressure, it should be maintained at ≤ 30cmH2O. Respiratory rate should also be adjusted according to the patient’s rate to avoid asynchrony. Prone positioning is recommended in patient with moderate to severe form of hypoxemia (PaO2/FiO2 < 150 mm Hg) ideally within the first 48 hrs of ARDS recognition. 14 DOH Guidelines for Leptospirosis for Hospitals This maneuver requires 3-5 people, paying close attention to endotracheal tube (ETT) and central lines. Make sure that patient has an empty stomach. Steps in prone positioning: 1. Pre-oxygenation 2. Suction endotracheal tube and oral cavity 3. Remove ECG leads and reattach to back after shifting position. 4. Turn over the patient to the prone position. 5. Do repeated zeroing of hemodynamic transducers 6. Support and frequently reposition pressure points: face, shoulder, anterior pelvis Successful trials evaluating prone positioning in ARDS used at least 16 hours of daily proning. When PaO2/FiO2 remained > 150 mm Hg 4 h after supinating (with PEEP < 10 cm H2O and FiO2 < 0.6), stop prone positioning. C. Extracorporeal Membrane Oxygenation (ECMO) in leptospirosis The benefits of ECMO use in severe pulmonary form of leptospirosis and associated ARDS are still under evaluation. ECMO has been used more extensively as a potential bridge therapy in patients with severe ARDS and/or massive hemoptysis. The best outcome in ECMO for adult respiratory failure occurs when ECMO is instituted early after the onset (1-2 days). ECMO is done in a highly specialized center with a trained multi-disciplinary team. Should ECMO be considered, prompt referral and close coordination should be done to such centers who can perform the procedure. IX. RENAL COMPLICATIONS OF LEPTOSPIROSIS Renal complications of leptospirosis may present in a spectrum which may span from sterile pyuria , tea colored urine, mild proteinuria to severe anuric acute renal failure. Commonly it may present as non-oliguric renal failure with mild hypokalemia. Oliguria with hyperkalemia may reflect the severity of AKI and may connote poor prognosis. Oliguria is defined as urine output < 0.5 mL/kg/hr or <400mL/day or a self-report of decreased or no urine output within the last 12 hours. 15 DOH Guidelines for Leptospirosis for Hospitals The following are the list of diagnostic tests that should be performed when AKI is suspected: CBC with platelet count BUN, creatinine, sodium, potassium, AST, ALT, bilirubins Urinalysis Chest x-ray – check for congestion and/or signs of pulmonary hemorrhage The algorithm below (Figure 2) is a guide in the management of leptospirosis patients that present with oliguria. The recommended initial fluid resuscitation for Leptospirosis patient is Balanced crystalloids. If potassium is in the high normal value or with hyperkalemia, Isotonic saline is recommended. Hydroxyethyl starch should be NOT be given because it is associated with increased risk of Acute Kidney Injury, need for Renal Replacement and mortality. The recommended initial fluid resuscitation rate is 20ml/kg/h or 500ml of crystalloids within 15- 30mins Patients with Leptospirosis are prone to ARDS due to downregulation of the Na transport via Epithelial Sodium Channel (ENaC), NaKATPase as well as decrease in Aquaporin P5. Any one of the following are indications for dialysis: Uremic symptoms- nausea, vomiting, altered mental status, seizure, coma pH 3 mg/dl in ABG Serum K >5 meq in an oliguric patient ARDS, pulmonary hemorrhage (GRADE: moderate) Hemodialysis is preferred over peritoneal dialysis in patients with AKI secondary to Leptospirosis. The latter is a valid option if hemodialysis machine is not readily available. Daily dialysis is suggested to maintain strict control of azotemia and fluid volume which can improve survival for those patients with severe Leptospirosis especially if with pulmonary hemorrhage. 16 DOH Guidelines for Leptospirosis for Hospitals with oliguria leptospirosis Figurepatients for Algorithm 2. 17 DOH Guidelines for Leptospirosis for Hospitals X. PREVENTION AND CONTROL A. Hygienic conditions should be encouraged in slaughterhouses, farmyard buildings and bathing pools B. Avoidance of exposure to urine and tissues from infected animals such as wading in flooded areas. Likewise, activities in possible contaminated bodies of water should be prevented. C. Vaccination of animals against leptospirosis D. Rodent control E. When a potential exposure to contaminated water is anticipated, individuals should wear protective clothing (boots, gloves, spectacles), cover skin lesions with waterproof dressings, wash or shower after exposure to contaminated water, and wash and clean wounds. F. Avoid drinking water from possible contaminated water sources. G. Chemoprophylaxis (see next section) XI. CHEMOPROPHYLAXIS The use of chemoprophylaxis requires prior consult with a physician. It should not be taken unless prescribed and fully explained by a physician, including common side-effects and contraindications. Since antibiotic prophylaxis is not 100% effective, individuals should continue to monitor themselves for fever and other flu- like symptoms and should continue to wear personal protective measures when contact with contaminated water is anticipated. A. Pre-exposure Prophylaxis Pre-exposure antibiotic prophylaxis is NOT ROUTINELY RECOMMENDED. However, this may be considered for short-term exposures in those individuals who intend to visit highly endemic areas AND are likely to get exposed, including but not limited to: Travelers Soldiers People who engage in water-related recreational and occupational activities Disaster relief workers deployed to flooded or post-typhoon areas Doxycycline 200mg orally once a week, to begin 1 to 2 days before exposure and continued throughout the period of exposure. 18 DOH Guidelines for Leptospirosis for Hospitals B. Post-exposure prophylaxis Post-exposure prophylaxis is given following contact with contaminated sources such as flood water, animal carcasses, infected body fluids, etc. The post- exposure prophylactic regimens depends on the risk for leptospirosis following the exposure (see Table 7). Table 8. Post-exposure prophylaxis for leptospirosis in adults and children ADULTS MILD MODERATE HIGH RISK single exposure, non-mucosal, no mucosal exposure, presence or When there is repeated or breaks in the skin wound continuous exposure Doxycycline 200mg single dose, Doxycycline 200 mg once daily Doxycycline 200 mg once immediately within 24 to 72 hours for 3-5 days to be started weekly until the end of from exposure immediately within 24 to 72 hours exposure from exposure CHILDREN13 First-line: Doxycycline 4 mg/kg single dose, max dose: 200 mg Alternative: Azithromycin 10 mg/kg single dose, max dose: 500 mg* Amoxicillin 50 mg/kg/day q 6 hrs for 3-5days, max dose: 500 mg q6 hrs** Note: * Efficacy for prevention of leptospirosis was seen in vitro and animal models ** No clinical trial for prevention of leptospirosis, but amoxicillin is a known alternative for the treatment of disease Doxycycline has been known to cause permanent discoloration or enamel hypoplasia in developing teeth (among fetuses and children). There are currently no good quality evidence on pre- or post-exposure prophylaxis among children and pregnant patients. However, the American Academy of Pediatrics recently released a new statement saying that short course doxycycline therapy (i.e. <21 days) is not expected to cause teeth discoloration in children <8 years.14 As such, the Pediatric Infectious Disease Society has come up with chemoprophylactic recommendations for children. For pregnant patients, the use of azithromycin or amoxicillin post- exposure may be justifiable based on the reasons stated in Table 7 (note). 19 DOH Guidelines for Leptospirosis for Hospitals XII. REFERENCES 1. Marquez A, Djelouadji Z, Lattard V, Kodjo A. Overview of laboratory methods to diagnose Leptospirosis and to identify and to type leptospires. Int Microbiol. 2017;20(4):184-193. doi:10.2436/20.1501.01.302 2. World Health Organization Southeast Asia Regional Office. Leptospirosis - Fact Sheet. http://www.searo.who.int/about/administration_structure/cds/CDS_leptospirosis- Fact_Sheet.pdf. Accessed July 4, 2019. 3. Yanagihara Y, Villanueva S, Yoshida S, Okamoto Y, Masuzawa T. Current status of leptospirosis in Japan and Philippines. Comp Immunol Microbiol Infect Dis. 2007;30:399-413. 4. United Nations Office for the Coordination of Humanitarian Affairs. Philippines Typhoon Season 2009 Situation Report#14 (30 October 2009).; 2009. 5. Republic of the Philippines Department of Health. Leptospirosis Quarterly Surveillance Report No. 4 (2018).; 2018.https://portal2.doh.gov.ph/sites/default/files/statistics/ 2018_Leptospirosis_QSR_N4.pdf. Accessed July 4, 2019. 6. Roxas EA, Alejandria MM, Mendoza MT, Roman ADE, Leyritana KT, Ginete-Garcia JKB. Leptospirosis Outbreak after a Heavy Rainfall Typhoon in the Philippines: Clinical Features, Outcome and Prognostic Factors for Mortality. Acta Med Philipp. 2016;50(3):121-128. https://www.actamedicaphilippina.org/article/6866-leptospirosis-outbreak-after-a-heavy- rainfall-typhoon-in-the-philippines-clinical-features-outcome-and-prognostic-factors-for- mortality. Accessed July 4, 2019. 7. Amilasan A-ST, Ujiie M, Suzuki M, et al. Outbreak of leptospirosis after flood, the Philippines, 2009. Emerg Infect Dis. 2012;18(1):91-94. doi:10.3201/eid1801.101892 8. Collaborative Statement of the Philippine Society for Microbiology and Infectious Diseases, Philippine Society of Nephrology and the Philippine College of Chest Physicians Council on Critical Care and Pulmonary Vascular Diseases. The Philippine Clinical Practice Guidelines on the Diagnosis, Treatment and Prevention of Leptospirosis in Adults 2010. 2010. 9. Brato D, Mendoza M, Cordero C, et al. Validation of the World Health Organization (WHO) Criteria Using the Microscopic Agglutination Test (MAT) as the Gold Standard in the Diagnosis of Leptospirosis. PJMID. 27(4):125-128. 10. Brett-Major DM, Coldren R. Antibiotics for leptospirosis. Cochrane Database Syst Rev. 2012;(2):CD008264. doi:10.1002/14651858.CD008264.pub2 11. ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, et al. Acute Respiratory Distress Syndrome. JAMA. 2012;307(23):2526-2533. doi:10.1001/jama.2012.5669 12. Organized jointly by the American Thoracic Society, the European Respiratory Society, the European Society of Intensive Care Medicine, and the Société de Réanimation de Langue Française, and approved by ATS Board of Directors, December 2000. International Consensus Conferences in Intensive Care Medicine: Noninvasive Positive Pressure Ventilation in Acute Respiratory Failure. Am J Respir Crit Care Med. 2001;163(1):283-291. doi:10.1164/ajrccm.163.1.ats1000 13. Pediatric Infectious Disease Society of the Philippines. POST DISASTER INTERIM ADVICE ON THE PREVENTION OF LEPTOSPIROSIS IN CHILDREN. 2012. 14. American Academy of Pediatrics Committee on Infectious Diseases, Kimberlin D, Brady M, Jackson M, Long S. Red Book 2018-2021 Report of TheCommittee on Infectious Diseases. 31st ed.; 2018. https://redbook.solutions.aap.org/book.aspx?bookid=2205. Accessed July 4, 2019. 20 DOH Guidelines for Leptospirosis for Hospitals APPENDICES Appendix A. Modified Faine’s Criteria (2012) This check-list is designed for those who deal directly with the patient. It may be used even before results of leptospiral diagnostic tests are available. To use the this, give the appropriate score if the parameter is present for the patient and compute for the sum. MODIFIED FAINE’S CRITERIA (2012) Clinical data Epidemiological Bacteriological and laboratory (Part A) factors (Part B) findings (Part C) Headache 2 Rainfall 5 Isolation of leptospira in culture - Diagnosis certain Fever 2 Contact with 4 PCR 25 contaminated Environment Temperature >39°C 2 Animal contact 1 Serology Conjunctival suffusion 4 ELISA IgM positive* 15 Meningism 4 SAT positive* 15 Conjunctival suffusion 10 Other rapid tests** 15 + Meningism + Myalgia Jaundice 1 MAT – single positive in 15 high titer Albuminuria/Nitrogen retention 2 MAT – rising 25 titer/seroconversion Hemoptysis/Dyspnea 2 * Any one of the tests only should be scored ** Latex agglutination test/Lepto dipstick/Lepto Tek lateral flow/Lepto Tek Dri-Dot test Presumptive diagnosis of leptospirosis is made if: Part A or Part A and Part B score: 26 or more Parts A, B, C (Total): 25 or more A score between 20 and 25 suggests leptospirosis as a possible diagnosis. Table adapted from: Shiva Kumar, S. Indian Guidelines for the Diagnosis and Management of Human Leptospirosis (2013), p. 26. Accessed on 4 July 2019 from http://www.apiindia.org/medicine_update_2013/chap07.pdf 21 DOH Guidelines for Leptospirosis for Hospitals nd Submission nd a n Specimen Collection, Storage, Transport n Specimen Transport Collection, Storage, i Appendix B: Guidelines Appendix Guidelines B: 22 DOH Guidelines for Leptospirosis for Hospitals 23 DOH Guidelines for Leptospirosis for Hospitals 24 DOH Guidelines for Leptospirosis for Hospitals Chapter 2: UPSURGE POLICIES AND PROCEDURES I. STATEMENT OF PURPOSE AND SCOPE A. Purpose It is the purpose of this manual to define the actions and roles necessary to provide a coordinated response during an upsurge in leptospirosis cases in the HEALTHCARE FACILITY. This manual provides guidance to all the Departments within the HEALTHCARE FACILITY, with a general concept of potential Upsurge assignments before, during, and following a Leptospirosis Upsurge. It also provides for the systematic integration of Upsurge resources when activated including purchasing of necessary supplies and materials for renal replacement therapy, supporting the provision of necessary services, and even upgrading the facilities of the areas assigned to become temporary “leptospirosis wards.” Important as well is the allocation of financial support or resources from government agencies such as the Department of Health (DOH), specifically the Health Emergency Management Bureau (HEMB) and the Field Implementation and Coordination Team for NCR. It also includes activation of communications networking with relevant government, non-government agencies and media focusing on the prophylaxis, prevention and early treatment of leptospirosis. B. Scope This plan applies to all participating Divisions/Departments within the HEALTHCARE FACILITY. II. KEY POLICIES A. Criteria for Activation of the Leptospirosis Upsurge Policy The Leptospirosis Upsurge Policy will be activated when there is a surge in the number of leptospirosis patients requring admission to the HEALTHCARE FACILITY to ensure that patients receive appropriate and timely medical care, renal replacement and respiratory support using the HEALTHCARE FACILITY criteria to guide health care: Opening of a Leptospirosis Ward The HEALTHCARE FACILITY will identify the CRITICAL NUMBER OF PATIENTS BEING ADMITTED FOR LEPTOSPIROSIS PER DAY that will activate the policies and procedures in this handbook. When this critical number of patients who require more than simple hydration (i.e. renal replacement 25 DOH Guidelines for Leptospirosis for Hospitals therapy, blood component transfusion or requiring respiratory support) is reached, a Leptospirosis Ward will be identified and opened for these patients. Stable patients who do not require ventilatory support will be placed in the Leptospirosis Ward, while toxic patients who are unstable, requiring inotropic support, ventilatory support or who require intensive monitoring as they are likely to need intubation, will be admitted to the regular wards. Unstable patients will be placed in a special identified ward with a higher nurse to patient ratio. B. Person Responsible for Activation of the Leptospirosis Upsurge Policy DURING OFFICE HOURS from Monday-Friday, 8:00AM - 5:00PM, the Head Nurse and Head Consultant of the Emergency Room (ER) will inform the Executive Office if the criteria for activation of the Leptospirosis Upsurge Policy has been met. Any one of the Deputy Executive Directors or the Chief of Hospital will activate the Leptospirosis Upsurge Policy. Upon Activation of the Leptospirosis Upsurge Policy, the Secretary of any of the Deputy Executive Directors or Chief of Hospital will send out a memorandum through Outlook, and will notify the Heads of the following Departments / Divisions: Divisions of Adult and Pediatric Nephrology Division of Internal Medicine Division of Organ Transplantation and Vascular Surgery Nursing Services - All Head Nurses or Charge Nurses in all Clinical Wards - Operating Room (OR) Department of Pathology and Laboratory Medicine Section of Pulmonary Medicine Pharmacy, Procurement, Supply, Central Supply and Sterilization Unit (CSSU), Housekeeping, Billing and Claims, Admitting and Discharge Medical Social Services Division (MSSD) Information Resource Management Division (IRM) - Upload Hospital Memorandum regarding the activation of the Leptospirosis Upsurge Policy to all concerned departments through OUTLOOK - Inform all Heads of the concerned Department/Division including the Chief of Hospital and Deputy Executive Directors through SMS HEALTHCARE FACILITY-HEMB 26 DOH Guidelines for Leptospirosis for Hospitals AFTER OFFICE HOURS from Monday-Friday, weekends and holidays, the ER Charge Nurse will contact the Senior House Officer (SHO) who will activate the Leptospirosis Upsurge Policy and inform IRM to disseminate the information. (See Diagram I) ER Chief of Hospital and Senior House All Other Deputy Executive Directors Officers (SHO) Departments IRM All Medical Nursing Depts/Divisions Deploy Memo through All Nursing OUTLOOK to all those Departments on Duty and all the their Heads by SMS Diagram I: Activation of Leptospirosis Upsurge Policy after Office Hours C. Activation of the Leptospirosis Upsurge Management Team Once the Leptospirosis Upsurge Policy is activated, the Chief of Hospital or any of the Deputy Executive Directors will call on a meeting of the Leptospirosis Upsurge Management Team, to coordinate efforts on ensuring adequate provisions of necessary services for the leptospirosis patients. Meetings can be called on daily to update the entire team of the needs of the Leptospirosis ward and other areas. A Leptospirosis Upsurge Management Team Head will be assigned by the Chief of Hospital. This team is composed of the following: Chief of Hospital/Deputy Executive Director/s – Head Chair, Departments/Divisions of Adult and Pediatric Nephrology, Internal Medicine, Vascular, Laboratory Medicine Deputy Executive Director for Nursing Services ER Head Head Nurse of ER, Clinical Wards, HD Unit, PD Unit, Operating Room Head of Housekeeping, Purchasing, Warehouse, Pharmacy, CSSU, PBSD, MSSD, IRM, HEALTHCARE FACILITY-HEMB 27 DOH Guidelines for Leptospirosis for Hospitals D. Critical Bed Status Procedure – HEALTHCARE FACILITY Leptospirosis Upsurge Policy It is the goal of this Policy to provide a systematic method for identifying the available hospital beds, to unload the ER, to ensure that beds are being appropriately used during critical bed status, and to prevent the denial of transfers from other government hospitals during a Leptospirosis Upsurge. This is to ensure that patients receive proper medical care. Procedure: The post duty Senior Adult Nephrology Fellow will report on the total bed status and availability, to the Head of the Leptospirosis Upsurge Management Team by 8:00AM every morning. The Chief Fellow / Resident will prioritize admissions of the Leptospirosis patients especially those who need RRT or require ventilator support. E. Standards for Admission of Leptospirosis Patients All patients with a presumptive diagnosis of Leptospirosis will be triaged under the Division of Internal Medicine with the following criteria: 1. Serum Creatinine: < 3 mg/ dl 2. Absence of Criteria for Pulse Therapy All patients with a presumptive diagnosis of Leptospirosis will be triaged under the Division of Adult Nephrology (Patients > 19 yo) or Pediatric Nephrology (Patients < 18 yo and 364 days) with the following criteria: 1. Serum Creatinine: > 3 mg/ dl 2. Presence of any ONE of the Criteria for Pulse Therapy (See Appendix A) 28 DOH Guidelines for Leptospirosis for Hospitals III. ROLES AND RESPONSIBILITIES OF THE VARIOUS DEPARTMENTS / DIVISIONS / SECTIONS IN THE MANAGEMENT OF A LEPTOSPIROSIS UPSURGE A. Emergency Room (ER) Provide emergency medical treatment, triage patients and ensure administrative or clinical backup for the ER. Stamp clinical charts with “LEPTOSPIROSIS” so that the Pharmacy, CSSU and other concerned areas will be alerted that the requests should be provided, without pre-approval by MSSD. Refer patients who fulfill the criteria for Leptospirosis immediately to Nephrology or Internal Medicine. Patients developing acute kidney injury, who fulfill the criteria for renal replacement will be treated without delay. This should be provided to all patients and will not require MSSD pre-approval. The Head of the ER should ensure that the Leptospirosis Prophylaxis Survey 2013 is completed for all patients and placed in the clinical chart of the patient. The Chief Fellow of the Division of Adult Nephrology should collect the survey forms including forms from Pediatric Nephrology and Internal Medicine. (See Appendix B) The Head Nurse of the ER shall ensure that the ER Procedure Room is adequately prepared for use and will maintain adequate sterility for dialysis access procedures. The appropriate measures to maintain sterility of the area especially between procedures will be applied. ER Nephrology fellows shall refer patients requiring access placement for either hemodialysis (HD) or peritoneal dialysis (PD) to the Department of Vascular Surgery / General Surgery. Placement of a temporary HD catheter will be done either in the ER Procedure Room or Operating Room (OR) to ensure that there is no delay in dialysis access placement. Placement of HD access may also be performed by the Nephrology Fellow as per Division of Adult Nephrology protocol. Placement of a temporary PD catheter will be done in the OR only. The Head Nurse of the ER shall ensure that there are enough supplies for either HD or PD access placement, sufficient number of cut-down sets and other supplies necessary at the ER. These should be provided to all patients and will not require MSSD pre-approval. Any problems with supplies should be communicated immediately to the Head of the Leptospirosis Upsurge Management Team, Head of Warehouse, CSSU, and Purchasing. - For HD access – use triple lumen catheters - For intubation – use ET tube with subglottic suction 29 DOH Guidelines for Leptospirosis for Hospitals Residents and fellows shall refer patients to MSSD for completion of clinical information for inclusion as a service patient, and for possible application for the PhilHealth Leptospirosis benefit or other funding agencies to assist the HEALTHCARE FACILITY in sourcing funds for these patients. Residents and fellows shall refer patients who will require admission to the clinical wards (for patients on inotropes, require ventilator support, or who are clinically unstable) to the appropriate Medical Department/Division for facilitation of admission, while all other patients will be admitted to the Leptospirosis Ward. B. Division of Internal Medicine Assess patients and ensure that they are given adequate hydration, appropriate antibiotics and that patients are monitored. The Division is also responsible for following the Leptospirosis algorithm for proper diagnosis, management and documentation. The ER Medical Residents on duty are in charge of providing an efficient patient flow, consultation, and disposition at the ER. ◊ Patients will be admitted to the appropriate pay or service beds as necessary. The total daily number of patients admitted under the IM Service will be reported to the post duty Senior Adult Nephrology Fellow who will be responsible for consolidating the DAILY CENSUS of patients with Leptospirosis. Medical service residents will manage, monitor and provide proper medical disposition of patients admitted under IM service. If necessary, the service resident will transfer patients to nephrology service once the patient requires intravenous methylprednisolone pulse therapy and renal replacement therapy. Subspecialty service rotators will work in conjunction with nephrology fellows to manage difficult and complicated Leptospirosis cases. Rotators are also responsible for referring cases to the subspecialty consultant of the month. Medical service residents assigned to the Leptospirosis Ward will be responsible for answering urgent calls for patients admitted under IM service in the Leptospirosis Ward, in the absence of a nephrology fellow, and promptly refer to the service consultant. Medical Staffing of the Leptospirosis Ward is seen in Section V. 30 DOH Guidelines for Leptospirosis for Hospitals C. Divisions of Adult and Pediatric Nephrology Assess patients, provide renal replacement therapy / hydration as needed, and ensure that appropriate medications are administered. Nephrology fellows prioritize admissions based on the medical needs of patients. The NKTI is the tertiary referral center for renal disease for all DOH hospitals and will accept referrals from these hospitals for renal replacement. DOH hospitals with RRT services referring patients to NKTI will be reported to the Head of the Leptospirosis Upsurge Management Team and to DOH. Patients who fulfill the criteria for renal replacement will be allocated to either HD or PD according to the algorithm in Appendix A and C. Since the patients are diagnosed with acute kidney injury, this illness is reversible and all the needs for dialytic therapy, antibiotics and other therapeutics will be provided. The Division of Adult Nephrology will serve as the lead Department in consolidating the census for all patients seen at the ER and admitted, including basic demographics, treatment and outcome. (See Appendix D) The post duty Senior Adult Nephrology Fellow will be responsible for consolidating the 24-hour daily census of patients with Leptospirosis from all Departments at 12:00AM using the appropriate form (See Appendix D). This will be emailed to the Chief of Hospital, the Head of the Leptospirosis Upsurge Management Team, the Chair of the Division of Adult Nephrology, and to the Epidemiology Bureau and HEMB Operations Center, under the Department of Health. The PD Fellow 1 will be in charge of the Leptospirosis Ward and all the other Leptospirosis patients during office hours. After office hours, the PD Fellow 2 will take over and endorse the patients back to PD Fellow 1 in the morning. Nephrology Staffing of the Leptospirosis Ward is seen in Section V. The Head of the Leptospirosis Upsurge Management Team will coordinate with any of the concerned Departments/Divisions/Sections of HEALTHCARE FACILITY, as needed, to ensure that patients are treated in a timely manner, and to ensure that all the patients' needs are provided. The Head of the Leptospirosis Upsurge Management Team will update the Chief of Hospital / Deputy Executive Directors as necessary. The Head of the Leptospirosis Upsurge Management Team and/or the Chief of Hospital / Deputy Executive Directors, will attend the DOH-HEMB meetings, as necessary, to provide updates on the status of patients admitted at the HEALTHCARE FACILITY and to request for logistical support, if necessary. Nephrology Staffing of the Leptospirosis Ward is seen in Section V. 31 DOH Guidelines for Leptospirosis for Hospitals D. HEALTHCARE FACILITY-Health Emergency Management Bureau (HEMB) Team The HEALTHCARE FACILITY-HEMB Team will be included in the Leptospirosis Management Team. They will facilitate requests for augmentation of staffing and resources as necessary from the DOH-HEMB Office or the Field Implementation Coordination Team DOH-NCR. They will coordinate with the Head of the Leptospirosis Upsurge Management Team for any other needs. E. Division of Organ Transplantation and Vascular Surgery Responsible in providing timely insertion of temporary HD catheters or PD catheters and their removal, prior to patient’s final discharge and other surgical procedures if deemed necessary. F. Department of Pathology and Laboratory Medicine Responsible for processing of blood chemistry, hematology, transfusion requirements, microbiology, coagulation, and urinalysis available 24/7 for patients with Leptospirosis. Responsible for storage of blood for MAT, and to find out where these tests can be done at the lowest possible price. Shall ensure that the required clinical information is completed for the MAT tests. G. Section of Pulmonary Medicine Responsible for pulse oximetry, nebulization, arterial blood gas, and providing mechanical ventilatory support in a timely manner. The ECMO TEAM, headed by a Pulmonary consultant will decide whether or not referred leptospirosis patients fulfill the criteria for ECMO therapy. Once a patient is identified then the ECMO Team Head will activate the HEALTHCARE FACILITY multi-disciplinary ECMO Team to provide the necessary services for the patient. The ECMO Team head ensures the availability of ECMO supplies such as oxygenator, cannulaes and various tubings. Medical criteria for assisted ventilation and ECMO therapy is seen in Appendix E. H. Department of Medical Imaging and Therapeutic Radiology All radiologic services should be readily available to the ER, Leptospirosis and medical wards for all diagnostic studies and services utilizing the portable x- ray machine, ultrasound or CT scan as necessary. 32 DOH Guidelines for Leptospirosis for Hospitals I. Nursing Services Assures that there is adequate nursing staffing complement, equipment, medications and supplies, and that proper nursing care is provided. In preparation for the activation of the Leptospirosis Upsurge Policy a 1-week learning and development intervention on HD will be facilitated and scheduled at least once a year or as necessary. A similar workshop for PD will be facilitated at least once a year or as necessary to ensure that there are sufficient nurses in the ward adept at PD. This comprises 8-hours of a lecture workshop program and 40 hours of practicum. Senior staff nurses will be identified from each ward to undergo the HD and/or PD training as above. These nurses will be assigned to the Leptospirosis Ward once opened, and new staff nurses will be assigned to replace them in their respective units. Nurse Staffing of the Leptospirosis Ward is seen in Section V. J. Hemodialysis (HD) Unit The HD Unit Head will determine whether HD machines will be placed in the Leptospirosis Ward to facilitate HD treatments, so as not to disrupt the in- patients and ER patients requiring urgent HD. The guideline is when there are at least 16 patients requiring HD from the Leptospirosis Ward, 4-HD machine stations will be set-up in the Ward with portable reverse osmosis machines. Once a decision is made to set-up an HD Unit in the Leptospirosis Ward, the HD Unit Supervisor will contact the HEALTHCARE FACILITY’s HD provider to augment the number of HD machines and portable RO machines to be placed in the Leptospirosis Ward, and contact the Provider’s Facility. Engineer and Biomedical Engineer on duty to assess the area for setting up an HD Unit, such as the water and power source. The HD Unit Supervisor or Assistant will coordinate with all the wards where there are Leptospirosis patients to determine how many patients need HD and to schedule their treatments according to the prioritization level given by the Division of Adult Nephrology, and where the patients will have their HD treatments, ie. in the Leptospirosis Ward or in the HD Main Unit. If an HD Unit will be set-up in the Leptospirosis Ward, the following will be put in place: - 1 Computer Station - 1 Telephone Line - Sufficient HD supplies and on and off dressing kits 33 DOH Guidelines for Leptospirosis for Hospitals The HD Charge Nurse and HD technicians will prepare and set-up the HD Unit. The HD Unit Supervisor or Assistant will arrange for additional HD staff if necessary, to ensure that the provision of HD is not disrupted. An HD fellow should be present at all times when there are patients undergoing HD in the Leptospirosis Ward. All prescriptions for medications, supplies, dialysis orders and laboratories shall be stamped with “LEPTOSPIROSIS” so that the Pharmacy and CSSU will be alerted that the requests should be provided, without pre-approval by MSSD. K. Peritoneal Dialysis (PD) Unit Once the Leptospirosis Upsurge Policy is activated, the PD Unit Supervisor will contact the HEALTHCARE FACILITY’s PD Provider to augment the number of PD cycler machines as needed, to accommodate the increased number of patients who will be requiring PD and to request for additional PD Nurses to assist the PD Unit in providing PD services. The PD Unit Supervisor will ensure that there are sufficient supplies of PD catheters, solutions and accessories at all times, in coordination with Warehouse and Purchasing in all areas where Leptospirosis patients are admitted, especially in the Leptospirosis Ward. The PD Nurses will monitor all Leptospirosis patients who are started on PD therapy, whether manual or cycler-assisted. Patients will not be allowed to do their own PD exchanges while admitted in the wards. The PD nurses will ensure that PD is performed in a sterile manner and that there is no PD-related infection. The PD nurses will ensure that PD is done as prescribed, according to the prescription of the Nephrologist. The PD Nursing Attendant will assist the PD nurses in all activities related to PD. Once the patient is ordered discharged by Nephrology, the PD Nurse will ensure that the patient is referred back to Vascular Surgery for removal of the PD catheter prior to discharge. This should be performed in the OR. The PD Nurse will ensure that the appropriate charges for PD catheter removal are made. 34 DOH Guidelines for Leptospirosis for Hospitals L. Infection Prevention and Control Committee Tasked to monitor cases of Leptospirosis and to submit the cases to the DOH- Philippine Integrated Disease Surveillance and Response through master database system. The post duty Senior Adult Nephrology fellow will email to the IPCC Office the daily leptospirosis tally and census. M. Medical Social Services Division (MSSD) Facilitate care regarding the psychological and social needs of patients. The MSSD will provide staff that will be available 24 hours a day, 7 days a week with on-call coverage at all times during activation of the Leptospirosis Upsurge Policy. They are responsible for determining if patients are already members of PhilHealth, or are dependents of PhilHealth members, and if not, for completing all the information necessary for patients to enroll in PhilHealth at point-of-care. They will complete a database on all patients treated, demographics, the type of dialysis provided, if any, and outcome, dates of admission and discharge, referring hospital, financial assistance, PHIC membership and running charges. Since patients may develop reversible acute kidney or liver injury, all the medical needs should be provided without the need for pre-approval from MSSD. They will prepare the running balance of expenses related to Leptospirosis and submit regular reports to the Chief of Hospital and to the Head of the Leptospirosis Upsurge Management Team and other Executives. N. Pharmacy Division Responsible for making sure that patients receive the most appropriate medicines in the most effective and timely way. They prepare and dispense medications. All the Pharmacy requirements should be provided without the need for pre- approval from MSSD. They will ensure that the Leptospirosis Ward and other wards that have admitted Leptospirosis patients are provided with all the necessary medications (See Appendix A and C) such as: - Amoxicillin suspension 250mg/5ml - IV Penicillin G 1.5M units/vial 35 DOH Guidelines for Leptospirosis for Hospitals - IV Ceftriaxone 1 gram/vial - IV Hydrocortisone 100mg/ampule - IV Methylprednisolone 500mg/vial - IV Cyclophosphamide 1gram/vial - IV Potassium chloride 2meq/ml, 5ml/vial - IV Calcium gluconate 10%/vial - IV Magnesium sulfate 50%/vial The following should also be available in sufficient quantities: - Doxycycline 200mg/cap - Amoxicillin 500mg/cap - Omeprazole 40mg/amp - IV Plain NSS 1liter/ bottle - Dopamine 200mg/5ml vial - Norepinephrine 1mg/ml, 10ml vial - Dobutamine 250mg/25ml vial O. Housekeeping Section Tasked to set up the Leptospirosis Ward once ordered by the Head of the Leptospirosis Upsurge Management Team for a maximum of 50-cot beds. (See Part IV) P. Procurement and Supply Management Divisions Strategize, lead and manage logistics to ensure operational effectiveness. It includes ensuring the hospital has sufficient inventory to manage the Leptospirosis Upsurge, and that all inventory are accurately accounted for at all times. They will manage and direct the timely and cost effective supply of goods. All purchases in relation to the treatment of Leptospirosis patients or in augmenting supplies or equipment for the Leptospirosis Ward shall be reported on a weekly basis and submitted to the Head of the Leptospirosis Upsurge Management Team, the Chief of Hospital and to the Deputy Executive Director for Hospital Support Services. The Head of Procurement and Supply Management Divisions must inform the Head of the Leptospirosis Upsurge Management Team immediately if there are problems with stocks required to support the services for the Leptospirosis Ward. 36 DOH Guidelines for Leptospirosis for Hospitals Q. Central Supply and Sterilization Unit (CSSU) Responsible for supplying all of the wards of the hospital with all of the supplies necessary to complete daily operations. They are in charge of keeping the hospital's storage facilities stocked with adequate supplies for HD, PD, dialysis access, cut down sets etc. The following should be available in sufficient supply: - Paper tape - Endotracheal tube standard - Hand sanitizer - Endotracheal Tube with subglottic - Cotton balls suction - Povidone-iodine - Nasogastric tube - Alcohol - HD triple lumen catheters for right - Foley catheters and left internal jugular vein - Cut down set - PD catheters (Adult and Pediatric) R. Billing and Claims Division They are responsible for the preparation of hospital bills for Leptospirosis patients. They are responsible for submitting claims to PhilHealth for point-of-care benefit, as well as the routine claims for PhilHealth members. They will provide reports to Management on a weekly basis on the total subsidy by the HEALTHCARE FACILITY for Leptospirosis patients in coordination with MSSD. They will coordinate with IRM to ensure that patients are charged with the appropriate room rates when they are admitted to the Leptospirosis Ward. S. Admitting and Discharge Section They will facilitate admission of patients with Leptospirosis to the designated Leptospirosis Ward or service beds, and ensure that the appropriate room rates are charged for service patients. The Admitting “face sheet” shall be stamped with “LEPTOSPIROSIS” so that the Wards, Pharmacy, CSSU and other concerned areas will be alerted that the medical diagnostics and treatments should be provided, without pre- approval by MSSD. 37 DOH Guidelines for Leptospirosis for Hospitals T. Information Resource Management Division (IRM) Responsible for the management of data within HEALTHCARE FACILITY, to ensure a seamless coordination with the different Departments. They will set-up the computer stations in the Leptospirosis Ward Nurses Station with connectivity to the Medsys and radiology system and for the HD unit set-up in the Leptospirosis Ward. They will ensure that charges for use of the ER-OR for removal of either HD or PD catheters are included in the patient's final hospital bill, even if the patient is admitted in the wards. U. Nutrition and Dietetics Division (NDD) They will provide meals for all patients in the Leptospirosis Ward. They will provide meals for the HEALTHCARE FACILITY staff and augmented staff from other hospitals assigned to the Leptospirosis Ward. Once there are more than 100 patients admitted for Leptospirosis, in excess of the total number of in-patient beds, they will do emergency purchase of food items and other supplies to ensure the continuous supply of meals. 38 DOH Guidelines for Leptospirosis for Hospitals IV. SETTING UP A LEPTOSPIROSIS WARD Once the Leptospirosis Ward is opened, the following should be put in place for a 30 to 50 bed ward by the Housekeeping Unit: Patient cots Oxygen gauge IV stands Oxygen tank 1 watcher chair per patient Oxygen mask Bed linens 1 Disposable thermometer per patient BP Apparatus Infusion pumps Wheel chairs with IV stand The following may be placed in the Leptospirosis Ward if needed: Extension wires for the infusion pumps, coolers, PD cyclers, HD machines etc. Air Coolers or industrial fans Freezers or ice chests Water dispenser A Nurses Station will be put in place in a strategic area in the Leptospirosis Ward to ensure accessibility to communications. The Nurses Station will be equipped with the following: 3 Computer stations with access to charging of supplies etc., access to the HEALTHCARE FACILITY COMMUNICATIONS MODULE for laboratories etc. and 1 printer 2 Telephone units Forms: laboratory requests, admitting forms, order sheets, TPR sheet, input/output sheet etc. Patient folders or clipboards Basic medical supplies for patients HD access catheters, PD catheters and supplies Dressing kits and cut-down sets Other logistics such as industrial electric fans, ice for the fans etc. may be requested from the Housekeeping Section The PD Unit will be informed for transfer of PD cycler machines as needed. All prescriptions for medications, supplies, dialysis orders and laboratories shall be stamped with “LEPTOSPIROSIS” so that the Pharmacy and CSSU will be alerted that the requests should be provided, without pre-approval by MSSD. 39 DOH Guidelines for Leptospirosis for Hospitals V. STAFFING REQUIREMENTS IN THE LEPTOSPIROSIS WARD A. Medical Staffing in the Leptospirosis Ward The goal for medical staffing is to maintain a doctor-patient ratio of 1:20. The Adult Nephrology PD fellow 1 is assigned to cover the Leptospirosis Ward until a maximum of 20 patients. The PD fellow 2 goes on night duty at the Leptospirosis Ward. Pediatric Nephrology fellows make rounds on their patients only, but do not go on duty at the Leptospirosis Ward. Once there are more than 10 pediatric patients at the Leptospirosis Ward then a Pediatric Nephrology fellow will go on duty in the area. One Internal Medicine resident is also assigned to the Leptospirosis Ward once it opens. Once there are >20 to 40 patients, the PD senior and GN senior fellows are called to augment staffing on rotation to maintain at least 2 Nephrology fellows at any time. At this point, fellows from outside rotations and elective rotations will be recalled to assist in going on duty in the Leptospirosis Ward. A Nephrology fellow must be at the Leptospirosis Ward while there are patients undergoing HD in the area. Seriously ill patients are admitted to the regular hospital wards (ie. require inotropes, active bleeding, require oxygen support). Thus, relatively stable patients, dialysis-dependent, hydration requiring alone, are confined in the Leptospirosis Ward. Once the Leptospirosis Ward reaches a capacity of 40 patients or more, the Senior Nephrology Fellow will inform the Head of the Leptospirosis Upsurge Management Team and the Chief of Hospital to request for external staff augmentation from other Institutions to help in monitoring of patients. The HEALTHCARE FACILITY Chief of Hospital will inform the DOH-Field Implementation and Coordination Team-NCR, of the need for medical staff augmentation. Physicians with experience in attending to general medical patients will be preferred. They will report to the Chief Adult Nephrology Fellow for assignment. 40 DOH Guidelines for Leptospirosis for Hospitals B. Nurses Staffing in the Leptospirosis Ward Once the HEALTHCARE FACILITY has 30 patients admitted, they will be placed in the identified “Leptospirosis Ward” and the Leptospirosis Critical Extension Ward (for Patient Classification System (PCS) Level IV). 12 nurses, 6 nursing attendants and 1 clerk from the different units of HEALTHCARE FACILITY will be identified and pulled-out and assigned to the Leptospirosis Ward. Three nurses and 1 nursing attendant will be assigned per shift with the nurse-patient ratio of 1:8-10. For leptospirosis patients on PD, a PD Unit Roving nurse will do the rounds on a regular basis to facilitate PD. Once the number of patients exceeds 30, the Deputy Executive Director for Nursing Services will inform the Head of the Leptospirosis Upsurge Management Team and the Chief of Hospital to request for external staff augmentation from other Institutions to help in monitoring of patients. The Head of the Leptospirosis Upsurge Management Team and/or Chief of Hospital will inform DOH-Field Implementation and Coordination Team-NCR, of the need for staff augmentation (physicians, nurses, nursing attendants etc.) The Assistant Coordinator of the Health Emergency Management Bureau (HEMB) of HEALTHCARE FACILITY will likewise be informed of the need for staff augmentation to coordinate with HEMB. Nurses staffing augmentation will be composed of 12 nurses and 6 nursing attendants to be assigned to either of the two identified units or to the ER. They will report to the Deputy Executive Director for Nursing Services or his/her representative for the assigned area of deployment. The Chief of Hospital and other Deputy Executive Directors may also call other Department of Health Hospitals, Army Hospitals or LGU Hospitals for assistance in augmenting the staffing needs. Once the number of leptospirosis cases decreases to thirty (30) and below, the augmentation team shall return to their respective hospitals. 41 DOH Guidelines for Leptospirosis for Hospitals VI. HEALTH CARE PROVIDER NETWORK (previously called as SDN) To guarantee access of patient with Leptospirosis to quality and affordable health services, without causing any financial burden it is important that a Health Care Provider Network be established. Under the Universal Health Care Law, RA 11223, Sec. 4.i. Health Care Provider Network refers to a group of primary to tertiary care providers, whether public or private, offering people-centered and comprehensive care in an integrated and coordinated manner with the primary care provider acting as the navigator and coordinator of health care within the network. An important key feature of a Health Care Provider Network is a functional Two-way Referral System which will help ensure the continuity of care from one health service facility to another. It Includes: 1. Transport system to move the patient from one facility to another 2. Establishment of two-way communication system 3. Interoperable information system 4. Clearly defined referral manual The NKTI is one of four specialty hospitals strategically situated in Metro Manila. As an end referral hospital for patients suffering from severe form of Leptospirosis with pulmonary and/or renal complication, maximization of its service capability utilization for targeted patient population can be achieved efficiently thru a functional service provider network currently being organized by DOH-FICT Team (NCR and MM). 42 DOH Guidelines for Leptospirosis for Hospitals VII. ANTIBIOTIC PROPHYLAXIS FOR LEPTOSPIROSIS For relatives of patients and HEALTHCARE FACILITY employees with a history of flooding in flooded waters, the following prophylaxis should be given: A. Recommended post-exposure prophylaxis for Leptospirosis for adults (San Lazaro Hospital’s Guideline on Prophylaxis for Leptospirosis 2009) LOW-RISK EXPOSURE is defined as those individuals with a single history of wading in flood or contaminated water without wounds, cuts or open lesions of the skin. Doxycycline 200 mg single dose within 24 to 72 hours from exposure [Grade B] MODERATE-RISK EXPOSURE is defined as those individuals with a single history of wading in flood or contaminated water and the presence of wounds, cuts, or open lesions of the skin, OR accidental ingestion of contaminated water. Doxycycline 200 mg once daily for 3-5 days to be started immediately within 24 to 72 hours from exposure [Grade C] HIGH-RISK EXPOSURE is defined as those individuals with continuous exposure (those having more than a single exposure or several days such as those residing in flooded areas, rescuers and relief workers) of wading in flood or contaminated water with or without wounds, cuts or open lesions of the skin. Swimming in flooded waters especially in urban areas infested with domestic/ sewer rats and ingestion of contaminated water are also considered high risk exposures. Doxycycline 200 mg once weekly until the end of exposure [Grade B] B. Recommended post-exposure prophylaxis for Leptospirosis for pregnant women Amoxicillin 500 mg/tab 1 tab BID x 3 days If allergic to amoxicillin, may give erythromycin 250 mg BID x 3 days 43 DOH Guidelines for Leptospirosis for Hospitals C. Recommended post-exposure prophylaxis for Leptospirosis for children From the Post Disaster Interim Advice on the Prevention of Leptospirosis in Children. August 10, 2012. Pediatric Infectious Disease Society of the Philippines, Inc. Drug Dose Comments Doxycycline 4mg/kg single Proven efficacy for preventing clinical dose, disease. Max: 200mg Adverse effects are similar to other tetracyclines; in children below 8 years of age, doxycycline is unlikely to cause dental staining at the dose and duration recommended to treat serious infections. Avoid milk, dairy products, iron and antacids 1 hour before and 2 hours after administration; may be given with food to avoid stomach upset. Alternative Drugs Efficacy for prevention of leptospirosis Azithromycin was seen in vitro and animal models. Amoxicillin 50mg/kg/day No clinical trial for prevention of divided into 4 leptospirosis, but amoxicillin is known doses for 3-5 alternative for the treatment of disease. days Dose is for 3-5 days due to the very short Max: 500mg half-life. q6H If children are exposed for more than 7 days, the dose should be repeated after 1 week. *This algorithm for Leptospirosis was made by the NKTI-Department of Pediatric Nephrology: Dr. Zenaida Antonio Dr. Ofelia De Leon Dr. Ma. Angeles Marbella Dr. Ma. Lorna Lourdes Simangan Dr. Violeta Valderama Dr. Norma Zamora Dr. Coe Dela Seña 44 DOH Guidelines for Leptospirosis for Hospitals APPENDICES Appendix A. Algorithm for Leptospirosis (Revised August 2013) Fever, Conjunctival Suffusion, Muscle Aches History of Wading In Flood Waters +/- Icterisia, Jaundice DIAGNOSTICS: INITIAL MANAGEMENT: 1. CBC with platelet count 1. Fast drip 2 liters Plain NSS 2. Creatinine, Sodium, Potassium Calcium, (May insert 2 IV Lines) then continue hydration at Albumin, Lipase 300 cc/ hour 3. ABG as needed 2. Start Penicillin-G at 1.5million units IV every 6 hrs 4. Baseline ECG OR Ceftriaxone 1gram IV OD, if patient fulfills 5. Chest PA criteria for Pulse Therapy.* 6. PT, PTT Daily if needed 7. LAT IgG and IgM 8. If negative for both, send serum for IgM and IgG after 7 days 9. Send out specimen for Microscopic Agglutination Test (MAT) care of Laboratory Medicine Department *CRITERIA FOR PULSE THERAPY (any one) 1. Platelet count less than 100,000 2. SBP less than 90mm Hg after isotonic fluid resuscitation of 2L 3. Requires inotropes 4. Lung infiltrates on Chest Xray 5. Prolonged PT, PTT YES NO Give Methylprednisolone 500 mg/ IV after HD OD Patient requires dialysis** x 3 days. Platelet count >100,000 but less than After the 3rd Methylprednisolone dose or after 150,000 any episode of hemoptysis, give Cyclophosphamide 1 gm IV as a single dose after HD YES NO Give Ceftriaxone 1 gm IV OD (instead of Penicillin G) Give Omeprazole 40 mg IV OD Give hydrocortisone 100 mg IV every 6 *If the patient has been started on Hydrocortisone IV, hours give the remaining steroid dose to reach the target Continue IV Penicillin G dose of MPP 500 mg/ day (see steroid conversion). Give Omeprazole 40 mg IV OD Then give the Methyprednisolone 500 mg IV OD on days 2 and 3. *Steroid conversion: Hydrocortisone 5mg = Methyprednisolone 1mg PROCEED TO ALGORITHM FOR DIALYSIS THERAPY 45 DOH Guidelines for Leptospirosis for Hospitals ALGORITHM FOR DIALYSIS THERAPY Urine output: <500cc/day AND/OR Creatinine: >3 mg/dl YES NO FULFILLS ANY OF THE CRITERIA Continue hydration FOR PULSE THERAPY Do serial laboratory monitoring YES NO Do Acute Do acute PERITONEAL DIALYSIS (APD) HEMODIALYSIS 1. APD 1.5%, 1.5L per exchange, dwell time 30 min x 40 exchanges. May use hypertonic exchange if patient needs fluid removal. 2. Hydrocortisone 100mg IV q6 hrs x 3 days 3. Omeprazole 40 mg 1 tab OD If with improving creatinine, urine output and better well-being, step down antibiotic to Doxycycline 100mg BID on day 1, then 100mg OD thereafter OR Amoxicillin 500mg QID, to complete 7 days. * This algorithm for Leptospirosis was made by NKTI Multi-Disciplinary Team composed of: Dr. Romina Danguilan, Department of Adult Nephrology Dr. Myrna Mendoza, Internal Medicine, Section of Infectious Disease Dr. Ernesto Que, Internal Medicine, Section of Gastroenterology Dr. Joselito Chavez, Internal Medicine, Section of Pulmonary Medicine 46 DOH Guidelines for Leptospirosis for Hospitals Appendix B. Leptospirosis Prophylaxis Survey For Patient Name: Date of Admission: Address: Age/Sex: Chief Complaint: Exposure to Flood: Yes No Date of Exposure: Duration in Days: Number of Times Exposed: Wounds on Exposed Area to the Flood: Yes No Ingestion of Flood Water: Yes No Prophylaxis Taken: Yes No Drugs Used and Dosage: Doxycycline 100mg 2x/day for days Amoxicillin 500mg 2x/day for days Initial Sign/Symptom: Signs and Symptoms Began: Total number of household members including patient: How many were EXPOSED to flood? Fill-in for Each Household Member EXPOSED Type of Household Member: Family (state relation to patient): Non-family (state role in household): Name: Age/Sex: Date of Exposure: Duration in Days: Number of Times Exposed: Wounds on Exposed Area to the Flood: Yes No Ingestion of Flood Water: Yes No Prophylaxis Taken: Yes No If Yes, Drugs Used and Dosage: Doxycycline 100mg 2x/day for days Amoxicillin 500mg 2x/day for days Sign and Symptom: 47 DOH Guidelines for Leptospirosis for Hospitals Appendix C. Algorithm for Leptospirosis (Pediatric Patients) SUSPECTED LEPTOSPIROSIS Fever for 2 days plus History of wading in flood water plus Nonspecific signs and symptoms (conjunctival suffusion, headache, myalgia, vomiting, diarrhea, abdominal pain, difficulty of breathing) + jaundice/icterisia DIAGNOSTICS CBC; BUN creatinine, serum Na, K, Ca, SGPT Urinalysis Chest xray Leptospirosis LAT/MAT PT PTT ABGs MILD LEPTOSPIROSIS MODERATE-SEVERE LEPTOSPIROSIS (AKI-Risk) (AKI-Injury and Failure) Elevated serum creatinine, with or without hepatic involvement Stable vital signs, no jaundice Urine output < 0.5cc/kg/hr with pulmonary congestion/ Urine output > 0.5cc/kg/hr hemorrhage/ sepsis able to take oral medications Normal serum creatinine No evidence of pulmonary congestion/ hemorrhage/ sepsis ADMIT able to take oral medications CRITERIA FOR PULSE THERAPY Close follow-up Any one Give fluids based in fluid status 1. Platelet count <100,000 2. SBP < 90mm Hg after isotonic fluid resuscitation of 2L MAY SEND PATIENT HOME 3. Requires inotropes For children >8 years old, 4. Lung infiltrates on chest xray DOXYCYCLINE 100 mg PO BID on 5. Prolonged PT, PTT Day1 then 100 mg OD thereafter or 4mg/kg divided into 2 doses for less than 50kg For children 8 years old or less, YES NO Amoxicillin 30-50mg/kg/day q6 (max 500mg QID) or Give methylprednisolone 500mg Azithromycin 1g initial dose then 500mg OD or 10mg/kg/day OD for 3 IV after HD OD x 3 days Give ceftriaxone 1g IV OD days Low eGFR, high BUN, (instead of Penicillin G) UO > 0.5cc/kh/hr Give omeprazole 40mg IV OD stable vital signs (1) Low eGFR, high BUN, UO > 0.5cc/kg/hr stable vital signs (2) 48 DOH Guidelines for Leptospirosis for Hospitals Low eGFR, High BUN, (1) (Pediatric Patients) UO decrease 0.5cc/kh/hr stable vital signs CXR NO CONGESTION WITH CONGESTION Step A IV hydration 3- Step B Start furosemide 2-6mg/kg as IV 5cc/kg/hr bolus q6 or drip IVF M x 0.3 + UO Monitor UO Monitor UO Increase UO, stable vital No improvement, with signs, increase eGFR signs of congestion Continue hydration Proceed to step B Increase UO, stable vital No improvement, with signs, increase eGFR progression of congestion Continue step B Step C: Do RRT Decreased eGFR, increased BUN, UO increase 0.5cc/kh/hr (2) (Pediatric Patients) stable vital signs HYPOVOLEMIA EUVOLEMIA HYPERVOLEMIA PNSS 20cc/kg/hr IV fast PNSS 20cc/kg IV fast drip + signs of congestion drip upto 3 doses or until euvolemic upto 2 doses With crackles Continue IVF depending Proceed to Step C on hydration status (mild/moderate/severe) No improvement, with Increase UO, stable vital signs of congestion signs, increase eGFR Increase UO, stable vital Proceed to Step C Continue Step A signs, increase eGFR Continue Step A No improvement, with signs of With signs of Increase UO, stable vital congestion congestion signs, increase eGFR Proceed to step B Proceed to Step C Continue step B If hypotensive, start inotropes: Dopamine drip if in cold shock, norepinephrine drip if in warm shock 49 DOH Guidelines for Leptospirosis for Hospitals Step C (Pediatric Patients) No improvement, with signs of congestion Proceed to Step C MILD CONGESTION MODERATE-SEVERE CONGESTION No acidosis, normal RR Intractable acidosis, increased RR + crackles BLF, no desaturation Crackles BLF, oxygen-requiring CAPD HEMODIALYSIS LEPTOSPIROSIS With Suspected Pulmonary Hemorrhage Cough, dyspnea, hemoptysis Give Methylprednisolone Continue Observation RR > 30 for children > 5yo 10-20mg/kg > 40 for children 1-5yo Max: 500mg IV Presence of the following: Continue Observation Discontinue Steroids Chest Xray-Bilateral Infiltrates No PF ratio < 250 OR SaO2< 90% at 6L/min via face Yes Intubate patient* and hook to mechanical ventilator Continue methylprednisolone 10-20mg/kg, max 500mg IV for 2 more days then Prednisone 1mg/kg/day x 7 days 50 DOH Guidelines for Leptospirosis for Hospitals Leptospirosis Census Format for Reporting for Format Census Leptospirosis D. Appendix 51 DOH Guidelines for Leptospirosis for Hospitals Appendix E. Criteria for Assisted Ventilation for Leptospirosis Patients Indications for BIPAP: Establish need for Ventilatory Assistance in an alert and cooperative patient: Moderate to severe respiratory distress Tachypnea (RR>24 breaths/min) Accessory muscle use or abdominal paradox pH <7.35, arterial PCO2>45mmHg or arterial PO2/FIO2<200 Exclude patients with contraindications to Non-invasive ventilation: Respiratory arrest Medically unstable (septic or cardiogenic shock, uncontrolled upper gastrointestinal bleeding, uncontrolled arrhythmias) Unable to protect airway Excessive secretions Uncooperative or agitated Unable to fit mask Recent upper airway or gastrointestinal surgery Indications for Intubation: Hypoxic respiratory failure: PaO2/FiO2 <200 (moderate ARDS) or O2 saturation <90% at 10 L/min face mask with rebreathing bag Hypercapneic respiratory failure: pH <7.2, PCO2 > 45mmHg Deterioration of sensorium Failure of noninvasive ventilation *Once intubated, co-manage with anesthesiologists for adequate sedation Indications for ECMO in Leptospirosis patients with pulmonary hemorrhage resulting in ARDS; Use of SOFA/ Murray Score to initially evaluate patient PaO2/FiO2 < 100 on FiO2> 90% and/or Murray score 3-4 despite optimal care for 6 hours or less. The best outcome in ECMO for adult respiratory failure occurs when ECMO is instituted early after onset (1-2 days). CO2 retention on mechanical ventilation despite high Pplat (>30 cm H2O) 52 DOH Guidelines for Leptospirosis for Hospitals Contraindications for ECMO: There are no absolute contraindications to ECMO. Each patient is considered individually with respect to benefits and risks. However, the following may be considered contraindications if present (based on HEALTHCARE FACILITY Protocol). Cardiac arrest Mechanical ventilation for more than 3 days CNS hemorrhage Nonrecoverable comorbidity such as major CNS damage or terminal malignancy Age: no specific age contraindication but consider increasing risk with increasing age Pancreatic enzymes: Lipase > 2x upper limit of normal References: Murray and Nadel’s Textbook of Respiratory Medicine ELSO Adult Respiratory Failure Guideline Murray Score 53 DOH Guidelines for Leptospirosis for Hospitals DEFINITION OF TERMS Upsurge An increase or an upward surge in the number of leptospirosis patients requiring hospital admission, wherein the hospital must augment bedspace availability to accommodate all of the patients GLOSSARY ER – Emergency Room HD – Hemodialysis MSSD – Medical Social Services Division OR – Operating Room PD – Peritoneal Dialysis RRT – Renal Replacement Therapy SHO – Senior House Officer 54 NOTES DOH Guidelines for Leptospirosis for Hospitals 55 NOTES DOH Guidelines for Leptospirosis for Hospitals 56 DOH Guidelines for Leptospirosis for Hospitals 57