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Update on Novel Shock Treatments and Approach to Utilization

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Update on Novel Shock Treatments and Approach to Utilization Update on Novel Shock Treatments and Approach to Utilization Kayla A. Nichols, BS, PharmD, BCCCP Clinical Pharmacist II, Critical Care Emory University Hospital Adjunct Clinical Instructor Mercer University College of Pharmacy Atlanta, Georgia [email protected] Click to edit Master text styles Disclosures I have nothing to disclose concerning possible financial or personal relationships with commercial entities (or their competitors) that may be referenced in this presentation. I will be discussing the off-label use of medications. Click to edit Master text styles Objectives • Review standard therapies frequently utilized for shock • Discuss novel and evolving therapies for shock • Corticosteroid review • Metabolic resuscitation • Angiotensin II • Methylene blue • Hydroxocobalamin • Apply novel therapies to current regimens often used in practice Click to edit Master text styles Before we tackle the new stuff Let’s review the old stuff Click to edit Master text styles Definition of Shock • A state of cellular and tissue hypoxia due to one or more of the following: • inadequate oxygen delivery • overconsumption of oxygen • inadequate oxygen utilization ClickJ Environ to edit Sci Master Health text A Tox styles Hazard Subst Environ Eng. 2012;47(7):920-39. Image: https://wesavelives.org/alyson-geller-dear-allstate/ Types of Shock: Cardiogenic • Reduction in pump function • Ex: myocardial infarction • Treatment: • Fluid optimization • Inotropes • Vasopressors ClickJ Environ to edit Sci Master Health text A Tox styles Hazard Subst Environ Eng. 2012;47(7):920-39. Image: http://trendintech.com/2018/05/30/researchers-develop-technique-that-can-remotely- operate-lab-grown-heart-cells/human-heart-anatomical-rendering-on-dark-background/ Types of Shock: Hypovolemic • Reduction of intravascular volume • Ex: trauma, high volume losses • Treatment: • Fluid resuscitation • Blood • Vasopressors ClickJ Environ to edit Sci Master Health text A Tox styles Hazard Subst Environ Eng. 2012;47(7):920-39. Image: https://www.kisspng.com/png-red-cell-a-red-blood-cell-311605/ Types of Shock: Obstructive • Impaired venous return • Decreased cardiac output • Ex: pulmonary embolism • Treatment: • Vasopressors • Removal of obstruction ClickJ Environ to edit Sci Master Health text A Tox styles Hazard Subst Environ Eng. 2012;47(7):920-39. Image: https://www.roadtrafficsigns.com/road-closed-signs Types of Shock: Distributive • Most common form of shock • Loss of microcirculatory autoregulation and/or increased metabolic demand • Ex: sepsis, vasoplegia • Treatment: • Fluid resuscitation • Vasopressors ClickJ Environ to edit Sci Master Health text A Tox styles Hazard Subst Environ Eng. 2012;47(7):920-39. Image: https://pixabay.com/en/pseudomonas-aeruginosa-bacteria-2034320/ Distributive Shock Wheelhouse Fluids Vasopressors +/- Steroids* *Individual practice varies Click to edit Master text styles Improving Blood Pressure: a Review Vasopressors Inotropes Epinephrine Vasopressin Dobutamine Norepinephrine Phenylephrine Milrinone Dopamine Click to edit Master text styles Corticosteroids: a review Click to edit Master text styles Hypothalamus-Pituitary-Adrenal Cortex Axis ClickComput to editBiol MasterMed. 2015 text stylesDec 1;67:1-12. Crit Care Med. 2001 Jul;29(7 Suppl):S117-20. Corticosteroids: two mechanisms 1) Anti-inflammatory: – Hypothalamic-Pituitary-Adrenal axis (HPA) – Reduced cytokine production 2) Cardiovascular – Cytokines cause peripheral decreased response to catecholamine receptor – Cortisol improves vasoconstrictor response to epinephrine in animal models ClickCrit Care to edit Med. Master 2001 text Jul;29(7 styles Suppl):S117-20. Eur J Pharmacol 1972;20:1–9 The Corticosteroid Controversy “High dose steroids suppress the sepsis induced inflammatory response” 1970s ClickCrit Care to edit Resusc. Master 2017 text stylesMar;19(1):3-4. Crit Care Med. 2014 Nov;42(11):2442-3. The Corticosteroid Controversy “High dose steroids increase the risk of infection and superinfection, thereby increasing morbidity” 1970s 1980s ClickCrit Care to edit Resusc. Master 2017 text stylesMar;19(1):3-4. Crit Care Med. 2014 Nov;42(11):2442-3. The Corticosteroid Controversy Annane et al: decrease mortality, reduced shock reversal time CORTICUS: no difference in responders vs non, decrease shock reversal time 1970s 1990s 1980s ClickCrit Care to edit Resusc. Master 2017 text stylesMar;19(1):3-4. Crit Care Med. 2014 Nov;42(11):2442-3. The Corticosteroid Controversy New England Journal of Medicine: ADRENAL 2018 APROCCHSS 2018 1970s 1990s 1980s 2018 Click to edit Master text styles Corticosteroids: Prior to 2018 • Annane showed a mortality benefit for non-responders that received hydrocortisone and fludrocortisone • Subsequent studies have failed to duplicate the benefits seen in this trial and even suggested infection-related harm • Hydrocortisone may lead to a more rapid reversal of shock • ACTH-stimulation test no longer used in practice Click to edit Master text styles Corticosteroids: 2018 update Click to edit Master text styles ADRENAL 2018 Objective • To determine if administration of corticosteroids reduce 90-day mortality in patients with septic shock requiring ventilator and vasopressor support Study Design • Multicenter, double-blind, parallel-group, randomized controlled trial • Continuous infusion of hydrocortisone 200mg IV daily for 7 days or ICU death/discharge vs placebo Population • N = 3,658 • Mechanically ventilated • Strong clinical suspicion of infection with ≥2 SIRS criteria • Continuous vasopressors/inotropes for SBP >90 mmHg or MAP > 60 mmHg for ≥4 hours ClickN Engl to J edit Med. Master 2018 textMar styles 1;378(9):797-808 ADRENAL 2018 Outcome Steroids (n = 1,832) Placebo (n = 1,826) Significance Mortality at 90 days (%) 27.9 28.8 HR 0.95; 0.82-1.10 Duration of ventilation (days) 6 7 HR 1.13; 1.05-1.22 Median time to shock reversal (days) 3 4 HR 1.32; 1.23-1.41 Median time to ICU discharge (days) 10 12 HR 1.14; 1.06-1.23 28 day mortality (%) 22.3 24.3 OR 0.89; 0.76-1.03 Blood transfusions (%) 37.0 41.7 OR 0.82; 0.72-0.94 Critiques: • Prior trials used bolus doses of steroids • Adverse events were recorded on clinical judgement ClickN Engl to J edit Med. Master 2018 textMar styles 1;378(9):797-808 APROCCHSS 2018 Objective • To determine if administration of hydrocortisone plus fludrocortisone therapy would improve the clinical outcomes of patients with septic shock Study Design • Multicenter, double-blind, 2 by 2 factorial, randomized trial • Hydrocortisone 50mg IV q6h and fludrocortisone 50 mcg daily for 7 days vs Placebo Population • N = 1,241 • Admitted to the ICU <7 days with indisputable or probable septic shock <24 hours • Clinically or microbiologically documented infection • SOFA 3-4 for ≥2 organ systems for ≥6 consecutive hours • Receipt of vasopressor therapy (≥0.25 mcg/kg/min or ≥1mg/hr) for ≥6 hours ClickN Engl to J edit Med. Master 2018 textMar1;378(9):809 styles -818. APROCCHSS 2018 Outcome Steroids (n=614) Placebo (n=627) Mortality at 90 days (%) 43 49 RR 0.88; 0.78-0.99 Mortality at 28 days (%) 34 39 RR 0.87; 0.75-1.01 Mortality at ICU discharge (%) 35 41 RR 0.86; 0.75-0.99 Mortality at hospital discharge (%) 39 45 RR 0.86; 0.76-0.98 Mortality at 180 days (%) 47 53 RR 0.89; 0.79-0.99 Vasopressor-free days at 28 days (days) 17 15 P < 0.001 Organ-failure-free days at 28 days (days) 14 12 P = 0.003 Critiques: • Trial conducted using the Surviving Sepsis 2008 Guidelines, which has since been updated • Patients were generally more ill limiting the generalizability ClickN Engl to J edit Med. Master 2018 textMar1;378(9):809 styles -818. Steroids: Role in Therapy • Corticosteroids accelerate time to shock resolution and weaning of vasopressors • To be determined: – Improvement in mortality – Optimal patient population – Optimal timing to initiate – Chronic steroid use and corticosteroids in shock – Adverse effects and risk Click to edit Master text styles What if the steroids aren’t enough? Click to edit Master text styles Metabolic resuscitation http://www.hrphysician.com/paulClick to edit Master text styles-e-marik-md/ What is metabolic resuscitation? ClickChest. to 2017 edit MasterJun;151(6):1229 text styles-1238 rationale.Pharmacol Ther. 2018 Apr 21 Crit Care Med. 2016Feb;44(2):360-7 Image: http://graphics.latimes.com/food-water-footprint/ What is metabolic resuscitation? Hydrocortisone 50mg IV q6h ClickChest. to 2017 edit MasterJun;151(6):1229 text styles-1238 rationale.Pharmacol Ther. 2018 Apr 21 Crit Care Med. 2016Feb;44(2):360-7 Image: http://graphics.latimes.com/food-water-footprint/ What is metabolic resuscitation? Hydrocortisone 50mg IV q6h Ascorbic acid 1500mg IV q6h ClickChest. to 2017 edit MasterJun;151(6):1229 text styles-1238 rationale.Pharmacol Ther. 2018 Apr 21 Crit Care Med. 2016Feb;44(2):360-7 Image: http://graphics.latimes.com/food-water-footprint/ What is metabolic resuscitation? Hydrocortisone 50mg IV q6h Ascorbic acid 1500mg IV q6h Thiamine 200mg IV q12h ClickChest. to 2017 edit MasterJun;151(6):1229 text styles-1238 rationale.Pharmacol Ther. 2018 Apr 21 Crit Care Med. 2016Feb;44(2):360-7 Image: http://graphics.latimes.com/food-water-footprint/ Marik 2017 Objective • To determine if vitamin C, thiamine, and hydrocortisone provides a mortality benefit in patients with severe sepsis or septic shock Study Design • Retrospective before-after study • Ascorbic acid + thiamine + hydrocortisone vs. hydrocortisone alone or no therapy Population • N = 194 • Primary diagnosis of severe sepsis or septic shock • Procalcitonin ≥2 ClickChest. to 2017 edit MasterJun;151(6):1229 text styles-1238 Marik 2017 Primary Outcome: In-Hospital Mortality (%) 45 41.6 40.4 40 39.1 35 30 25 P < 0.001 20 15 10 8.5 5 0 HC + B1 + Vit C Control Predicted Actual ClickChest. to 2017 edit MasterJun;151(6):1229 text styles-1238 Next steps • The VItamin C, Thiamine And Steroids in Sepsis (VICTAS) Study – Sponsored by Emory University • Evaluation of Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Septic Shock (HYVITS) – Sponsored by Hamad Medical Corporation ClickChest.
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