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

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborator: Shriners Hospitals for Children
• Treatments: Fenofibrate

Criteria

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