Hydrocortisone plus Fludrocortisone for Adults with Septic Shock
Journal Club Summary
Question and Methods: Large multi-center, double-blinded, randomized-controlled trial comparing effects of steroids (fludrocortisone + hydrocortisone) to placebo on 90-day mortality of ICU patients in septic shock on vasopressors for at least 6 hours.
Findings: Use of steroids reduced 90-day mortality (43% vs 49.1% for placebo, p=0.03), with a NNT = 17. There were no differences in rates of serious adverse events.
Limitations: Original study design had to be changed partway—could not study one of the intended drugs (Activated Protein C). Results of the corticotropin tests were not reported.
Interpretation: Given primary outcome findings, statistically significant secondary outcomes, and safety profile, in patients with septic shock requiring vasopressors for at least 6 hours, clinicians should be using steroids (hydrocortisone and fludrocortisone).
By: Dr. Sarah-Taissir Bencharif
Survival analyses are used in clinical trials that follow patients over time for primary outcomes such as death, relapse, adverse drug reaction, or development of a new disease. The follow-up time may range from hours to years and a different set of statistical procedures are employed to analyze the data. Terms frequently seen in papers with survival analyses include Cox proportional hazard model, hazard ratio, Kaplan-Meir curve.
By: Dr. Venkatesh Thiruganasambandamoorthy