N Engl J Med. 2008 Jan 10;358(2):111-24.

Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, Weiss YG,
Benbenishty J, Kalenka A, Forst H, Laterre PF, Reinhart K, Cuthbertson BH, Payen
D, Briegel J; CORTICUS Study Group.

Hadassah Hebrew University Medical Center, Jerusalem, Israel 91120.
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BACKGROUND: Hydrocortisone is widely used in patients with septic shock even
though a survival benefit has been reported only in patients who remained
hypotensive after fluid and vasopressor resuscitation and whose plasma cortisol
levels did not rise appropriately after the administration of corticotropin.
METHODS: In this multicenter, randomized, double-blind, placebo-controlled trial,
we assigned 251 patients to receive 50 mg of intravenous hydrocortisone and 248
patients to receive placebo every 6 hours for 5 days; the dose was then tapered
during a 6-day period. At 28 days, the primary outcome was death among patients
who did not have a response to a corticotropin test. RESULTS: 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). At 28 days, there was no
significant difference in mortality between patients in the two study groups who
did not have a response to corticotropin (39.2% in the hydrocortisone group and
36.1% in the placebo group, P=0.69) or between those who had a response to
corticotropin (28.8% in the hydrocortisone group and 28.7% in the placebo group,
P=1.00). At 28 days, 86 of 251 patients in the hydrocortisone group (34.3%) and
78 of 248 patients in the placebo group (31.5%) had died (P=0.51). In the
hydrocortisone group, shock was reversed more quickly than in the placebo group.
However, there were more episodes of superinfection, including new sepsis and
septic shock. CONCLUSIONS: Hydrocortisone did not improve survival or reversal of
shock in patients with septic shock, either overall or in patients who did not
have a response to corticotropin, although hydrocortisone hastened reversal of
shock in patients in whom shock was reversed. (ClinicalTrials.gov number,
NCT00147004.) 2008 Massachusetts Medical Society