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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Pioglitazone

Criteria

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