Conditions: Severe Sepsis Septic Shock
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics of pioglitazone and to determine the effect on inflammatory biomarkers for pioglitazone in patients with severe sepsis and septic shock.

Detailed description:
Severe sepsis is a major cause of morbidity and mortality among adults and children. Few clinical trials have demonstrated clinical benefit in sepsis. Severe sepsis is a systemic inflammatory syndrome in response to infection that is associated with acute organ dysfunction. The nuclear receptor peroxisome proliferator-activated receptor-gamma (PPARg) is involved in the regulation of the sepsis-induced inflammatory response. The central hypothesis is that pioglitazone reduces the inflammatory responses in children with severe sepsis and septic shock.

Arms:
arm 1: Pioglitazone hydrochloride treatment group arm 2: Normal standard care control group

Interventions: intervention 1: Pioglitazone hydrochloride
Intervention descriptions: intervention 1: Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.

Protocol document: