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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Severe Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Pioglitazone hydrochloride

Pioglitazone hydrochloride treatment group

Group Type EXPERIMENTAL

Pioglitazone hydrochloride

Intervention Type DRUG

Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.

Normal standard care

Normal standard care control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pioglitazone hydrochloride

Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.

Intervention Type DRUG

Other Intervention Names

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Actos

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No