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

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ClinicalTrials.gov Identifier: NCT01352182
Recruitment Status : Completed
First Posted : May 11, 2011
Results First Posted : September 2, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Drug: Pioglitazone hydrochloride Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Characteristics of Pioglitazone and Preliminary Biomarker Response in Adolescents Aged 12 to 17 Years With Severe Sepsis and Septic Shock
Study Start Date : October 2011
Actual Primary Completion Date : May 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
Experimental: Pioglitazone hydrochloride
Pioglitazone hydrochloride treatment group
Drug: Pioglitazone hydrochloride
Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.
Other Name: Actos

No Intervention: Normal standard care
Normal standard care control group



Primary Outcome Measures :
  1. Evaluate the Safety Profile of Pioglitazone in Patients With Severe Sepsis and Septic Shock as the Number of Hypoglycemic Events [ Time Frame: Assessement over five days ]
    The number of hypoglycemic events in pioglitazone vs standard care. Hypoglycemia was defined as blood glucose level that remains <40mg/dl despite dextrose bolus treatment.

  2. Safety Labs - Blood Urea Nitrogen (BUN) [ Time Frame: Final day of study ]
    BUN levels in blood from subject on the final day of enrollment

  3. Safety Labs - Creatinine [ Time Frame: Final day of study ]
    Creatinine levels in blood from subject on the final day of enrollment

  4. Safety Labs - Alanine Aminotransferase (ALT) [ Time Frame: Final day of study ]
    ALT levels in blood from subject on the final day of enrollment

  5. Pioglitazone Area Under Curve Estimates by Treatment Group and Route of Administration [ Time Frame: five days ]
    Pioglitazone concentration as the total area under curve divided by the number of days receiving the drug in subjects who took the drug by mouth versus by naso-gastric tube


Secondary Outcome Measures :
  1. Effect of Pioglitazone Area Under the Curve on Changes in IL-6 [ Time Frame: Evaluation of inflammatory biomarkers will be obtained prior to dosing for the first five days of the study ]
    We examined the effect of pioglitazone Area under the curve on IL-6 in patients receiving pioglitazone only. (Control subjects did not receive pioglitazone). The pharmacokinetic endpoint was area under the curve (AUC) total/days of pioglitazone administration



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352182


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Jennifer M. Kaplan, M.D., M.S. Children's Hospital Medical Center, Cincinnati
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01352182    
Other Study ID Numbers: PIOSEPSIS1217
First Posted: May 11, 2011    Key Record Dates
Results First Posted: September 2, 2020
Last Update Posted: September 2, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Sepsis
Toxemia
Pioglitazone
Shock, Septic
Shock
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Hypoglycemic Agents
Physiological Effects of Drugs