Annane Trial
Trial question
What is the role of low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 300
300 patients (100 female, 200 male)
Inclusion criteria: patients with septic shock and relative adrenal insufficiency
Key exclusion criteria: pregnancy, acute myocardial infarction, PE, advanced form of cancer or AIDS infection, and contraindication or formal indication for corticosteroids
Interventions
N=151 hydrocortisone and fludrocortisone (hydrocortisone 50 mg IV every 6 hours and fludrocortisone 50 µg PO once daily for 7 days)
N=149 placebo (matching placebos for 7 days)
Primary outcome
Death
53
63
63.0 %
47.3 %
31.5 %
15.8 %
0.0 %
Hydrocortisone and fludrocortisone
Placebo
Significant decrease ▼
NNT = 10
Significant decrease in death (53% vs. 63%; HR 0.67, 95% CI 0.47 to 0.95)
Secondary outcomes
Significant increase in the rate of withdrawal of vasopressor therapy within 28 days (57% vs. 40%; HR 1.91, 95% CI 1.29 to 2.84)
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with septic shock and relative adrenal insufficiency, hydrocortisone and fludrocortisone were superior to placebo with respect to death.
Reference
Annane D, Sebille V, Charpentier C et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71.
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