HYPRESS
Trial question
What is the effect of hydrocortisone on the development of shock among patients with severe sepsis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 353
353 patients (124 female, 229 male).
Inclusion criteria: patients with severe sepsis.
Key exclusion criteria: septic shock, younger than 18 years, known hypersensitivity to hydrocortisone or mannitol (placebo), history of corticosteroid medication with indication for continuation of therapy or other indications for treatment with corticosteroids.
Interventions
N=177 hydrocortisone (continuous infusion at a dose of 200 mg for 5 days followed by dose tapering until day 11).
N=176 placebo (lyophilized mannitol).
Primary outcome
Rate of septic shock within 14 days
21.2%
22.9%
22.9 %
17.2 %
11.4 %
5.7 %
0.0 %
Hydrocortisone
Placebo
No significant
difference ↔
No significant difference in the rate of septic shock within 14 days (21.2% vs. 22.9%; AD -1.8%, 95% CI -10.7 to 7.2).
Secondary outcomes
No significant difference in death at 28 days (8.8% vs. 8.2%; AD 0.5%, 95% CI -5.6 to 6.7).
No significant difference in death at 90 days (19.9% vs. 16.7%; AD 3.2%, 95% CI -5.1 to 11.4).
No significant difference in death at 180 days (26.8% vs. 22.2%; AD 4.6%, 95% CI -4.6 to 13.7).
Safety outcomes
No significant differences in secondary infections, weaning failure, muscle weakness, hypernatremia, or other adverse events.
Significant differences in hyperglycemia (90.9% vs. 81.5%), delirium (8.5% vs. 19.2%).
Conclusion
In patients with severe sepsis, hydrocortisone was not superior to placebo with respect to the rate of septic shock within 14 days.
Reference
Keh D, Trips E, Marx G et al. Effect of Hydrocortisone on Development of Shock Among Patients With Severe Sepsis: The HYPRESS Randomized Clinical Trial. JAMA. 2016 Nov 1;316(17):1775-1785.
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