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Table 1 Recently completed randomized, controlled trials of cortisol replacement in septic shock

From: Cortisol replacement for severe sepsis and septic shock: what should I do?

Study

Methods

Participants

Interventions

Outcome

Comments

Bollaert et al., 1998 [2]

Randomized, two-center, double blind, parallel groups

N = 41, adults only Vasopressor-dependent septic shock

Hydrocortisone, 300 mg per day (100 mg i.v. bolus) for 5 days and then either stopped (if no effect on shock reversal) or progressively tapered; or placebo

Shock reversal, death, complications

Improved time to shock reversal in 28-day survival No increase in complication rates

Briegel et al., 1999 [3]

Randomized, monocenter, double blind, parallel groups

N = 40, adults only Vasopressor-dependent septic shock

Hydrocortisone, loading dose of 100 mg in 30 min followed by continuous infusion 0.18 mg/kg per h for 6 days and then progressively tapered in steps of 24 mg/day; or placebo

Shock reversal, organ dysfunction, death

Improved time to shock reversal in organ dysfunction free-days No increase in complication rates

Chawla et al., 1999 [4]

Randomized, monocenter, double blind, parallel groups

N = 41, adults only Vasopressor-dependent septic shock

Hydrocortisone, 300 mg per day (100 mg i.v. bolus) for 5 days and then either stopped (if no effect on shock reversal) or progressively tapered; or placebo

Shock reversal, death, complications

Improved time to shock reversal in 28-day survival No increase in complication rates

Keh et al., 1999 [5]

Randomized, placebo-controlled, monocenter, double blind, crossover

N = 40, adults only Vasopressor-dependent septic shock

Hydrocortisone, loading dose of 100 mg in 30 min followed by continuous infusion 0.18 mg/kg per hour for 3 days; or placebo

Systemic inflammation, systemic and pulmonary hemodynamics, vasopressor requirement, complications

Improvement in systemic inflammation, hemodynamics, and vasopressor requirements No increase in complication rates

Annane, 2000 [6]

Randomized, placebo-controlled, multicenter, double blind, parallel groups

N = 300, adults only Vasopressor-dependent and ventilator-dependent septic shock

Hydrocortisone 200 mg/day (50 mg i.v. bolus) + fludrocortisone 50 μg/day (oral) for 7 days or their respective placebo

28-day survival, shock reversal, organ dysfunction reversal, complications

Improvement in shock reversal and mortality No increase in complication rates