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Procalcitonin-Guided Interventions Against Infections to Increase Early Appropriate Antibiotics and Improve Survival in the Intensive Care Unit: a Randomized Trial

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Procalcitonin-Guided Interventions Against Infections to Increase Early Appropriate Antibiotics and Improve Survival in the Intensive Care Unit: a Randomized Trial Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit: A randomized trial Jens U. Jensen, MD, PhD; Lars Hein, MD; Bettina Lundgren, MD, DMSc; Morten H. Bestle, MD, PhD; Thomas T. Mohr, MD, PhD; Mads H. Andersen, MD; Klaus J. Thornberg, MD; Jesper Løken, MD; Morten Steensen, MD; Zoe Fox, MD, PhD; Hamid Tousi, MD; Peter Søe-Jensen, MD; Anne Ø. Lauritsen, MD; Ditte Strange, MD; Pernille L. Petersen, MD; Nanna Reiter, MD; Søren Hestad, MD; Katrin Thormar, MD; Paul Fjeldborg, MD; Kim M. Larsen, MD; Niels E. Drenck, MD; Christian Østergaard, MD, PhD, DMSc; Jesper Kjær, MSc; Jesper Grarup, DVM; Jens D. Lundgren, MD, DMSc; for the The Procalcitonin And Survival Study (PASS) Study Group Objective: For patients in intensive care units, sepsis is a were supplemented with a drug-escalation algorithm and inten- common and potentially deadly complication and prompt initia- sified diagnostics based on daily procalcitonin measurements. tion of appropriate antimicrobial therapy improves prognosis. The Measurements and Main Results: The primary end point was objective of this trial was to determine whether a strategy of death from any cause at day 28; this occurred for 31.5% (190 of antimicrobial spectrum escalation, guided by daily measurements 604) patients in the procalcitonin arm and for 32.0% (191 of 596) of the biomarker procalcitonin, could reduce the time to appro- patients in the standard-of-care-only arm (absolute risk reduc- priate therapy, thus improving survival. tion, 0.6%; 95% confidence interval [CI] ؊4.7% to 5.9%). Length ؍ Design: Randomized controlled open-label trial. of stay in the intensive care unit was increased by one day (p Setting: Nine multidisciplinary intensive care units across .004) in the procalcitonin arm, the rate of mechanical ventilation Denmark. per day in the intensive care unit increased 4.9% (95% CI, 3.0– Patients: A total of 1200 critically ill patients were included 6.7%), and the relative risk of days with estimated glomerular after meeting the following eligibility requirements: expected in- filtration rate <60 mL/min/1.73 m2 was 1.21 (95% CI, 1.15–1.27). tensive care unit stay of >24 hrs, nonpregnant, judged to not be Conclusions: Procalcitonin-guided antimicrobial escalation in harmed by blood sampling, bilirubin <40 mg/dL, and triglycerides the intensive care unit did not improve survival and did lead to <1000 mg/dL (not suspensive). organ-related harm and prolonged admission to the intensive care Interventions: Patients were randomized either to the “stan- unit. The procalcitonin strategy like the one used in this trial dard-of-care-only arm,” receiving treatment according to the cannot be recommended. (Crit Care Med 2011; 39:000–000) current international guidelines and blinded to procalcitonin lev- KEY WORDS: antibiotics; bacterial infection; sepsis; mortality; els, or to the “procalcitonin arm,” in which current guidelines biomarker guidance; procalcitonin epsis, pneumonia, and menin- America (1–3). Clinicians in intensive ing Sepsis Campaign, and that prompt gitis are examples of infectious care units have recognized that an orga- institution of appropriate therapy, de- conditions that continue to nized and systematic approach to deliver- fined as delivering an antibiotic active S have a high mortality rate in ing interventions with proven efficacy is against the identified causative process intensive care units in Europe and North important, as emphasized in the Surviv- within a few hours of syndrome recogni- From the Copenhagen HIV Programme (JUJ, ZF, JK, thesia and Intensive Care (HT, PSJ) and Clinical Microbi- tion, the A.P. Moller Foundation, the Hurbec Founda- JG, JDL), University of Copenhagen, Copenhagen, Den- ology (CØ), Copenhagen University Hospital, Herlev, Den- tion, and the Capitol Region of Denmark. mark; the Departments of Clinical Microbiology (JUJ, BL) mark; the Department of Anaesthesia and Intensive Care J.U.J. received speaker fee and travel reimburse- and Anaesthesia and Intensive Care (JL, MS), Copenha- (NED, NR), Copenhagen University Hospital, Roskilde, ment from Brahms Diagnostica and received an unre- gen University Hospital, Hvidovre, Denmark; the Depart- Denmark; the Department of Anaesthesia and Intensive stricted grant for the organization for sample transport ment of Anaesthesia and Intensive Care (LH, AØL, DS, Care (KML), Aarhus University Hospital, Aarhus, Denmark; and analysis. The other authors have not disclosed any PLP), Copenhagen University Hospital, Glostrup, Den- and the Department of Infectious Diseases (JDL), Copen- potential conflicts of interest. mark; the Department of Anaesthesia and Intensive Care hagen University Hospital, Rigshospitalet, Copenhagen, Clinical trial registered with www.clinicaltrials.gov (LH, MHB, SH), Copenhagen University Hospital, Hillerød, Denmark. (NCT00271752). Denmark; the Department of Anaesthesia and Intensive Supplemental digital content is available for this ar- For information regarding this article, E-mail: Care (TTM, KJT, KT), Copenhagen University Hospital, ticle. Direct URL citations appear in the printed text and [email protected] Gentofte, Denmark; the Department of Anaesthesia and are provided in the HTML and PDF versions of this article Copyright © 2011 by the Society of Critical Care Intensive Care (MHA, PF), Aarhus University Hospital, on the journal’s Web site (www.ccmjournal.com). Medicine and Lippincott Williams & Wilkins Skejby, Denmark; Royal Free Hospital (ZF), University This study was funded, in part, by the Danish College London, London, UK; the Departments of Anaes- State, the Lundbeck Foundation, the Toyota Founda- DOI: 10.1097/CCM.0b013e31821e8791 Crit Care Med 2011 Vol. 39, No. 9 1 tion, is one of the most effective interven- MATERIALS AND METHODS different host responses to this were defined as tions for improving prognosis in the in- in the study by Levy et al (19). In the procal- tensive care setting (4–6). PASS is a randomized controlled trial con- citonin group, the use of antimicrobial inter- Clinician judgment is pivotal to ducted at mixed medical/surgical intensive care ventions was guided by the same clinical units in nine regional tertiary care public uni- guidelines as in the standard-of-care-only choosing the right drug or combination versity hospitals in Denmark in 2006–2009. group and additionally by daily procalcitonin of drugs for initial therapy of sepsis or Patients. To be eligible, patients had to be measurements classified as “alert procalci- other acute infections in the intensive Ն18 yrs of age, enrolled within 24 hrs of tonin” or “nonalert procalcitonin” with a cor- care unit. Given the plethora of commu- admission to the intensive care unit, and have responding obligatory intervention algorithm. nity- and hospital-acquired pathogens, an expected intensive care admission length of The interventional algorithm was available at and the increasing incidence of antimi- Ն24 hrs. Patients with known highly elevated all sites and all investigators were trained in it. crobial resistance, there is more risk that bilirubin levels (Ͼ40 mg/dL) or triglycerides Additionally, everyday, all sites were contacted Ͼ by telephone (365 days/yr) to assure that in- empiric therapy will fail to cover the ( 1000 mg/dL) were not eligible (interference with procalcitonin measurements). Addition- terventions were conducted according to the causative pathogen (7). ally, patients who were judged to be at an algorithm. The main principle in the interven- If a laboratory marker could be iden- increased risk from blood sampling were not tion algorithm was whenever an “alert procal- tified that would provide an early warning eligible. The inclusion criteria were broad be- citonin” occurred, 1) to substantially increase that antimicrobial therapy was inappro- cause infection is frequent and often causes the antimicrobial spectrum covered and 2) to priate, patient outcome might be im- complications in the patient group and to in- intensify the diagnostic effort to find uncon- proved. Procalcitonin, a fast-reacting bio- crease the external validity of the results. The trolled sources of infection, in this way inter- marker of bacterial infection (8), has person or next of kin gave informed consent. preting an “alert procalcitonin” as a warning The study protocol was approved by the re- of uncontrolled infection. “Alert procalci- been proposed as a tool to obtain this goal gional ethics committees in Denmark (H-KF- tonin” was defined as a procalcitonin Ն1.0 (9). Initial reports, summarized in a study 272-753) and adheres to the Helsinki declara- ng/mL that was not decreasing at least 10% by Uzzan et al (10), reported good perfor- tion revised in Seoul in 2008. from the previous day. At baseline, a single mance in critically ill patients; however, Procalcitonin Measurements. Samples procalcitonin measurement of Ն1.0 ng/mL more recent reports have observed a low were made straight after inclusion and there- was considered to be “alert procalcitonin.” performance of procalcitonin in this set- after everyday between 3:00 AM and 6:00 AM and Both arms received antimicrobial therapy ac- ting (11–13). Several trials have been subsequently collected at the intensive care cording to current guidelines. Culture sam- ples from blood, urine, airways, and other sus- conducted with the aim to use different unit by a courier who transported them to the central laboratory. They had to arrive before pected sites were performed according to the
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