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

Cincinnati Children's Hospital Medical Center logo

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

Trial design

12 participants in 2 patient groups

Pioglitazone hydrochloride
Experimental group
Description:
Pioglitazone hydrochloride treatment group
Treatment:
Drug: Pioglitazone hydrochloride
Normal standard care
No Intervention group
Description:
Normal standard care control group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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