Pharmacokinetic and Biomarker Study of Pioglitazone in Adolescents With Severe Sepsis and Septic Shock

Cincinnati Children's Hospital Medical Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

Severe Sepsis

Septic Shock

Treatments

Drug: Pioglitazone hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT01352182

PIOSEPSIS1217

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Weight range between 30 to less than or equal to 90kg
Have a known or suspected infection and meet criteria for severe sepsis or septic shock as defined according to the International Pediatric Sepsis Consensus Conference guidelines

Exclusion criteria

Are in a moribund state in which death is perceived as imminent
Have an advanced directive or do not resuscitate order to withhold life-sustaining
Have a history of cyanotic heart disease or congestive heart failure
Have a serum transaminase level (ALT) that exceeds about 2.5 times the upper limit of normal (>112 unit/L)
Are or become pregnant
Are already on or have a history of taking pioglitazone or rosiglitazone
Have type 1 or 2 diabetes
Have total body weight below 30 kg or above 90 kg
Have a serious condition, in addition to sepsis, which in the opinion of the investigator would compromise the participant