Can we use steroids to dampen the immune system in order to modify the “cytokine storm” associated with septic shock? This is a plausible concept that has been vigorously studied over many years.
The syndrome of Relative Adrenal Insufficiency (RAI) is thought to contribute to mortality, and therefore the question arises: if we replace endogenous cortisol with hydrocortisone, can we reduce mortality?
The CORTICUS Trial (NEJM 2008: 358(2); 111-124)
Are results valid?
- multicenter, randomized, double blind, placebo controlled
- Hydrocortisone 50mg QID for 5 days, 50 BD for day 6 - 8, then 50 daily for days 9 to 11
- 1 year follow up
- primary end-point rate of death at 28 days
- power calculation: 400 per group
- ITT analysis
- similar patient groups
Results?
- 251 patients received hydrocortisone, 248pts placebo
- baseline difference in death at 28 days in non-responders 38% versus responders 29% to SynACTHen test
- no difference for hydrocortisone v placebo overall in death at 28days
- wide confidence intervals reflecting limited sample size, not powered to find treatment effect
- In those who got Etomidate, 60.4% did not respond to SynACTHen, while in those who did not receive Etomidate only 43.4% (p=0.004) did not respond, and there was a significantly higher death rate
- duration of time until reversal of shock was shorter among all patients who got hydrocortisone (p<0.001), however total number of patients with reversal of shock unaffected
- increased risk of new episode of sepsis or septic shock with OR = 1.37 in those who received hydrocortisone
Can I apply the results to my patient group?
- Yes, similar population, similar baseline mortality
- treatment is feasible, but benefits of hydrocortisone do not clearly outweigh the harms
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