Phase 2
N=12
Pharmacokinetic and Biomarker Study of Pioglitazone in Adolescents With Severe Sepsis and Septic Shock
Severe Sepsis · Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT01352182 ↗Enrolled (actual)
12
Serious AEs
16.7%
Results posted
Sep 2020
Primary outcome: Primary: Evaluate the Safety Profile of Pioglitazone in Patients With Severe Sepsis and Septic Shock as the Number of Hypoglycemic Events — 0; 0 events — p=1.0
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pioglitazone hydrochloride (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Safety Profile of Pioglitazone in Patients With Severe Sepsis and Septic Shock as the Number of Hypoglycemic Events |
0; 0 | 1.0 |
| PRIMARY Safety Labs - Blood Urea Nitrogen (BUN) |
7.5; 10 | 1.0 |
| PRIMARY Safety Labs - Creatinine |
0.72; 0.415 | 0.154 |
| PRIMARY Safety Labs - Alanine Aminotransferase (ALT) |
21.5; 24.5 | 0.683 |
| PRIMARY Pioglitazone Area Under Curve Estimates by Treatment Group and Route of Administration |
5363; 1052 | 0.08 |
| SECONDARY Effect of Pioglitazone Area Under the Curve on Changes in IL-6 |
-1.4425; NA | 0.003 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01352182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.