CORTICUS Trial

NEJM

January 10, 2008

Hydrocortisone Therapy for Patients with Septic Shock.

Summarized by: 

Mazen Kherallah

What was the research question?

· Does hydrocortisone improve the 28-day mortality in patients with septic shock who have no response to corticotropin test?

How did they do it?

· Multicenter, randomized, double-blind, placebo-controlled trial in 52 ICUs.

· Total of 499 patients with septic shock within 72 hours of shock. All patients underwent corticotropin stimulation test to identify responders from non-responders.

· Patients were randomized to receive 50 mg of intravenous hydrocortisone (251 patients) or placebo (248 patients) every 6 hours for 5 days; the dose was then tapered during a 6-day period.

· Primary outcome was 28-day mortality among patients who did not have a response to a corticotropin test.

What did they find?

· Of the 499 patients in the study, 233 (46.7%) did not have a response to corticotropin (125 in the hydrocortisone group and 108 in the placebo group).

· 28-day mortality was not significantly different between the hydrocortisone group and the placebo group  (34.3% vs. 31.5%; p=0.51).

· No difference in 28-day mortality in the non-responders (39.2% vs. 36.1%; P=0.69) or the responders (28.8% vs 28.7%; P=1.00).

· The median time to reversal of shock was also shorter in the hydrocortisone group compared to the placebo group patients (3.3 vs 6.9 days; P<0.001).

· Superinfection including new sepsis and septic shock occurred at higher rate in the hydrocortisone group compared to placebo (33% vs 26%; RR 1.27 [0.96-1.68]).

· Hyperglycemia wasalso higher in the hydrocortisone group compared to placebo (85% vs 72%, RR 1.18[1.07-1.31].

Are there any limitations?

· Underpowered and potential type II error as it only enrolled 499 out of a projected 800 for adequate power.

What does it mean?

· Hydrocortisone did not improve survival but hastened the reversal of shock.

No need to do the corticotropin stimulation test

CORTICUS Trial