ESPEYB15 8 Adrenals Clinical Trials – New Treatments (2 abstracts)
ADRENAL Trial Investigators and the Australian–New Zealand Intensive Care Society Clinical Trials Group
To read the full abstract: N Engl J Med. 2018; 378(9): 797-808
Sepsis has been identified by the WHO as a global health priority, however, there has been no proven pharmacologic treatment other than the appropriate antibiotic agents, fluids and vasopressors as required. Reported death rates among hospitalized patients with sepsis range between 30-45% (22). Glucocorticoids have been used as an adjuvant therapy for septic shock for more than 40 years, however, uncertainty remains about their safety and efficacy (23).
Here, the authors performed a prospective randomized placebo controlled study in patients with septic shock on mechanical ventilation. Patients received hydrocortisone (at a huge dose of 200 mg per day) or placebo for 7 days or until death or discharge from the intensive care unit (ICU), whichever came first. The primary outcome was death from any cause at 90 days. They found that administration of hydrocortisone did not result in lower 90-day mortality than placebo among patients with septic shock. They observed a more rapid resolution of shock and a lower incidence of blood transfusion among patients who received hydrocortisone than among those who received placebo. Patients assigned to receive hydrocortisone had a shorter time to ICU discharge and earlier cessation of the initial episode of mechanical ventilation than those assigned to placebo. There were no other significant between-group differences. Patients assigned to receive hydrocortisone had more adverse events than did those assigned to placebo, but these events did not affect patient-centered outcomes. In conclusion, in patients with septic shock undergoing mechanical ventilation, continuous infusion of hydrocortisone did reduce mortality at 90 days. Thus a patient-related discussion of benefits versus harm between the pediatric intensivist and endocrinologist before administering hydrocortisone for septic shock would be recommended.
22. Reinhart K, Daniels R, Kissoon N, Machado FR, Schachter RD, Finfer S. Recognizing sepsis as a global health priority — a WHO resolution. N Engl J Med 2017; 377: 414-417.
23. Schumer W. Steroids in the treatment of clinical septic shock. Ann Surg 1976;184:333-341.