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Clinical Question
Does the early administration of hydrocortisone improve short-term outcomes in patients with septic shock?
Bottom line
In this small underpowered study in a single institution, it is unclear whether the early administration of hydrocortisone improves outcomes in patients with septic shock. 2b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Unknown/not stated
Setting: Inpatient (ICU only)
Synopsis
This study included 118 patients with septic shock (hypotension in spite of fluid resuscitation) who were admitted to an intensive care unit (ICU) in a single Chinese hospital. The researchers randomized the patients to receive hydrocortisone or normal saline within 6 hours of admission. The patients also received empiric antibiotics and fluid replacement (20 to 30 mL/kg for 30 to 60 minutes). If the patients were unable to achieve a mean arterial pressure of 65 mm Hg, they also were given vasopressors. In this small study, the patients who received hydrocortisone had higher APACHE II scores and were more likely to have signs of end-organ failure and the placebo-treated patients were more likely to have abdominal infections. Using intention-to-treat analysis, the authors found no statistically significant improvement in 28-day mortality (40% vs 32%), reversal of shock (66% vs 70%), ICU or hospital length of stay or in-hospital mortality. However, they planned their analysis for a much higher mortality rate than what they observed, so this report lacks the power to know for sure that hydrocortisone is ineffective. Finally, the authors re-analyzed their data and found that other factors potentially influenced the study outcomes, further undermining their ability to draw conclusions about the early administration of hydrocortisone. Overcoming the weaknesses of this study would require a large multicenter trial.
Reviewer
Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI
Comments
Hard to draw any useful (clinically applicable) conclusions from this. Agree; a multi-centre randomized controlled trial would be necessary to answer this question.
I thought that this issue had been studied to death in much better studies and that the conclusions ( lack of positive effect of steroids) had been decided a long time ago.
Why did you include this mediocre study in POEM?
More data needed
good poem
Excellent