Hydrocortisone Does Not Reduce the Risk of Septic Shock

Among adults with severe sepsis who are not in septic shock, use of hydrocortisone compared with placebo did not reduce the risk of septic shock within 14 days, according to a new study.

“To our knowledge, this is the first randomized clinical trial investigating the effects of hydrocortisone to prevent progression to shock in patients with severe sepsis presenting without shock,” the researchers said, noting the efficacy of hydrocortisone in patients with severe sepsis without shock remains controversial.
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The investigators conducted a double-blind, randomized clinical trial from January 13, 2009, to August 27, 2013, with a follow-up of 180 days until February 23, 2014. They performed the trial in 34 intermediate or intensive care units of university and community hospitals in Germany, and the researchers included 380 adult patients with severe sepsis not in septic shock.

They randomly allocated patients 1-to-1 either to receive a continuous infusion of 200 mg of hydrocortisone for 5 days followed by dose tapering until day 11 (n=190) or to receive placebo (n=190).

The intention-to-treat population consisted of 353 patients (64.9% male; mean age 65). Septic shock occurred in 36 of 170 patients (21.2%) in the hydrocortisone group and 39 of 170 patients (22.9%) in the placebo group.

The researchers observed no significant differences between the hydrocortisone and placebo groups for time until septic shock; mortality in the intensive care unit or in the hospital; or mortality at 28 days (15 of 171 patients [8.8%] vs 14 of 170 patients [8.2%]), 90 days (34 of 171 patients [19.9%] vs 28 of 168 patients [16.7%]), and 180 days (45 of 168 patients [26.8%] vs 37 of 167 patients [22.2%]).

In the hydrocortisone vs placebo groups, 21.5% vs 16.9% had secondary infections, 8.6% vs 8.5% had weaning failure, 30.7% vs 23.8% had muscle weakness, and 90.9% vs 81.5% had hyperglycemia.

“These findings do not support the use of hydrocortisone in these patients,” the researchers concluded.

—Mike Bederka

Reference:

Keh D, Trips E, Marx G, et al; SepNet–Critical Care Trials Group. Effect of hydrocortisone on development of shock among patients with severe sepsis: The HYPRESS Randomized Clinical Trial [published online October 3, 2016]. JAMA. doi:10.1001/jama.2016.14799.