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

Information source: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Severe Sepsis; Septic Shock

Intervention: Pioglitazone hydrochloride (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Children's Hospital Medical Center, Cincinnati

Official(s) and/or principal investigator(s):
Jennifer M. Kaplan, M.D., M.S., Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati

Overall contact:
Jennifer M Kaplan, M.D., M.S., Phone: 513-636-4259, Email: Jennifer.Kaplan@cchmc.org

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.

Clinical Details

Official title: Pharmacokinetic Characteristics of Pioglitazone and Preliminary Biomarker Response in Adolescents Aged 12 to 17 Years With Severe Sepsis and Septic Shock

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Evaluate the pharmacokinetic and safety profile of pioglitazone in patients with severe sepsis and septic shock

Secondary outcome: Examine the effect of pioglitazone treatment on inflammatory biomarkers of sepsis in patients with severe sepsis and septic shock

Detailed 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Jennifer M Kaplan, M.D., M.S., Phone: 513-636-4259, Email: Jennifer.Kaplan@cchmc.org

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting
Jennifer M Kaplan, MD, MS, Phone: 513-636-4259, Email: jennifer.kaplan@cchmc.org
Jennifer M. Kaplan, M.D., M.S., Principal Investigator
Additional Information

Kaplan Lab Page

Related publications:

Kaplan JM, Denenberg A, Monaco M, Nowell M, Wong H, Zingarelli B. Changes in peroxisome proliferator-activated receptor-gamma activity in children with septic shock. Intensive Care Med. 2010 Jan;36(1):123-30. doi: 10.1007/s00134-009-1654-6. Epub 2009 Sep 17.

Sherwin CM, Ding L, Kaplan J, Spigarelli MG, Vinks AA. Optimal study design for pioglitazone in septic pediatric patients. J Pharmacokinet Pharmacodyn. 2011 Aug;38(4):433-47. doi: 10.1007/s10928-011-9202-8. Epub 2011 Jun 11.

Starting date: October 2011
Last updated: December 15, 2014

Page last updated: August 20, 2015

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