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).
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.