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

Completed · Phase 1/Phase 2

Conditions studied: Severe Sepsis, Septic Shock

In brief

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.

Key facts

Study ID

NCT01352182

Run by

Children's Hospital Medical Center, Cincinnati

People needed

12

Starts

2011-10-01

Expected to finish

2017-01-01

Last updated by the study team

2020-09-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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