Randomized, placebo-controlled, double blinded trial of dexamethasone in African children with sepsis

Objective. To determine the effect of moderate dose dexamethasone administered before antibiotics on the outcome of African children with sepsis. Methods. The design was a randomized, double blinded, placebo- controlled trial of dexamethasone (0.2 mg/kg) vs. placebo given intravenously before antibiotic therapy. Patients were recruited from the patient populations at two missionary hospitals. Primary outcome variables were determined before analysis of data. Results. Seventy-two children with sepsis were enrolled in the study. Treatment with dexamethasone was not associated with improved outcome for any six outcome variables: survival to discharge (83%, dexamethasone group; 89%, placebo group); hemodynamic stability at 48 h (33%, dexamethasone group; 49%, placebo group); median length of hospital stay (11 days, dexamethasone group; 11 days, placebo group); normal at discharge (90%, dexamethasone group; 75%, placebo group); normal at follow- up (90%, dexamethasone group; 72%, placebo group); and afebrile at 48 to 72 h(61%, dexamethasone group; 44%, placebo group). Conclusions. These data indicate that a moderate dose of dexamethasone given before antibiotic therapy did not improve outcome in the pediatric patients with sepsis whom we studied.