Effect of Treatment With Low Doses of Hydrocortisone and Fludrocortisone on Mortality in Patients with Septic Shock

Overall Study Question

These investigators assessed whether low doses of corticosteroids could reduce mortality when given to patients with septic shock. The main endpoint was the 28-day survival in patients with relative adrenal insufficiency.

Patients

299 patients fulfilling the criteria for septic shock. Their average age was 61 and approximately 34% were female.

Treatment

Patients were randomized to receive either placebo or hydrocortisone 50 mg IV every 6 hours plus fludrocortisone 50 mcg daily for 7 days.  All patients received a corticotropin test to identify relative adrenal insufficiency.  Relative adrenal insufficiency (non-responders) was defined by a response of 9 mcg/dL or less.

Duration

The duration of follow up was 28 days.

Results

* p = 0.09, ** p = 0.06

NR= non responders/relative adrenal insufficiency, R = responders to corticotropin test,  NSS = not statistically significant

Other results

Adverse events rates were similar for each group.

How does this study contribute to the drug therapy of septic shock?

This study suggests that corticosteroids given to patients with septic shock and adrenal insufficiency decreases 28-day and ICU mortality.

Original Citation

Annane D,  Sébille V, Charpentier C, Bollaert P, François B, Korach J, Capellier G, Cohen Y, Azoulay E, Troché G, Chaumet-Riffaut P, Bellissant E. Effect of Treatment With Low Doses of Hydrocortisone and Fludrocortisone on Mortality in Patients With Septic Shock. JAMA 2002;288:862-71

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