TerminatedPhase 4

Acute and Long-Term Outcome Investigations of Fenofibrate on Severely Burned Patients

Stopped: lost funding; Shriner Burn Hosp has revoked access to study records. No updates or results can be submitted

United States3 participantsStarted 2012-05

Plain-language summary

The purpose of this study is to learn the following: whether long-term treatment (6 months) with fenofibrate will decrease burn related sugar and fat increased in the blood and help prevent muscle loss and improve wound healing.

Who can participate

Age range4 Years – 20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥40% Burn * ages 4-20years * body weight ≥10kg Exclusion Criteria: * \<40% burn * ages \<4-\>20 years * body weight \<10kg * Respiratory insufficiency * Multiple fractures * History of cancer in last 5 years * Bilirubin\>3mg/dL * Serum Creatinine\>3mg/dL after fluid resuscitation * Glutamyl-Oxaloacetic Transaminase(GOT) \>40 Units/L * Glutamyl-Pyruvate Transminase(GPT) \>51 Units/L * Associated head injuries requiring therapy * Associated injuries to the chest or abdomen requiring surgery * Receipt of any experimental drug other than the ones supplied within two months of study * Any metal in body including rods, cardiac defibrillators, pacemaker, etc * Orthopedic casting which would prevent placement in MRI * Hepatitis * Abnormal EKG * Electrical burns

What they're measuring

Mitochondrial fatty acid oxygenation

Timeframe: 6 months post injury

Trial details

NCT IDNCT01574131

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-02

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