"Corticosteroid Therapy of Septic Shock (CORTICUS)". The New England Journal of Medicine. 2008. 358(2):111-124. PubMed•ClinicalTrials.gov•Full
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Does administration of hydrocortisone improve survival among patients with septic shock, overall and among those who do not have a response to corticotropin?
In patients with septic shock, administration of hydrocortisone did not improve survival at 28 days, regardless of the patients' adrenal responsiveness to corticotropin, although it hastened the reversal of shock.
Corticosteroid use in septic shock has been a controversial topic, with previous research suggesting it might be beneficial particularly in patients with inadequate response to corticotropin. The CORTICUS study examined the effect of low-dose hydrocortisone on survival and shock reversal among a broad population of septic shock patients.
Current guidelines recommend the use of corticosteroids in septic shock only in certain circumstances, and previous results suggested potential benefits in non-responders to corticotropin.
Multicenter, randomized, double-blind, placebo-controlled trial.
499 patients hospitalized with septic shock.
- Hydrocortisone group (251 patients): Received 50 mg of intravenous hydrocortisone every 6 hours for 5 days, then tapered over a 6-day period. - Placebo group (248 patients): Received placebo at the same intervals.
- Primary Outcome: Death at 28 days among patients who did not have a response to corticotropin. - Secondary Outcomes: Death at 28 days among patients who had a response to corticotropin and among all patients, reversal of organ system failure, duration of the ICU and hospital stay, and safety assessed by recording adverse events.
- A lower number of participants was enrolled compared to the projected sample size, affecting the power of the study. - Etomidate, which can inhibit corticosteroid metabolism and was used prior to trial enrollment, may have confounded the results.
Supported by the European Commission, the European Society of Intensive Care Medicine, the European Critical Care Research Network, the International Sepsis Forum, and the Gorham Foundation. Roche Diagnostics supplied the cortisol assay.
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