Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation

Phase 2

Terminated

• Conditions: Burns
• Interventions: Procedure: Stable Isotope Infusion Study; Procedure: Collection of blood and tissues; Drug: Humatrope; Drug: Ketoconazole; Drug: Oxandrolone and propranolol combined; Drug: Placebo; Drug: Humatrope and propranolol combined; Behavioral: Exercise--Hospital supervised intensive exercise program; Behavioral: Home exercise program; Drug: Oxandrolone; Drug: Propranolol

• Registration Number: NCT00675714
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

The purpose of the program is to study and characterize the outcome of burn injury with particular attention to improving the rehabilitation of burn survivors, including children. Various agents are assessed for effectiveness on long term burn outcome, such as growth hormone, oxandrolone, propranolol,ketoconazole, inhospital exercise and home exercise.

Detailed Description

The University of Texas Medical Branch(UTMB) project improves outcomes for severely burned children by instituting and evaluating two modifications to traditional rehabilitation: (1) an intensive rehabilitation program including active resistance exercise; (2) long term administration of anabolic agents.

Effectiveness is assessed by comparison with functional outcomes achieved in traditional outpatient rehabilitation programs. Results indicate improvement in strength, endurance and bone density with these modifications. The project also maintains a longitudinal database that includes measures of cardiopulmonary function, growth and maturation, bone density, range of motion, and psychosocial adjustment.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-12
• Status Verified: 2018-08
• Primary Completion: 2018-09
• Study Completion: 2019-07-15
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1126

Inclusion Criteria

• Burn 30% Total Body Surface Area (TBSA) or greater
• Ages 0-80 yrs
• Negative pregnancy test
• Informed consent

Exclusion Criteria

• Untreated malignancy, known history of AIDS, Aids Related Complex, HIV
• Recent history of myocardial infarction (6 wks)
• Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases, autoimmune diseases
• Chronic glucocorticoid or non steroidal anti inflammatory drug therapy
• Diabetes mellitus prior to burn injury
• Renal insufficiency (defined by creatinine >3.0 mg/dl)
• Hepatic disease (bilirubin > 3.0 mg/dl)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Humatrope	Humatrope subcutaneous(SQ) 0.05-0.2 mg/kg/day for up to 2 years post burn
1	Collection of blood and tissues	Humatrope subcutaneous(SQ) 0.05-0.2 mg/kg/day for up to 2 years post burn
2	Ketoconazole	Ketoconazole by mouth (PO) given twice a day throughout hospitalization for up to 2 years post burn
3	Stable Isotope Infusion Study	Oxandrolone PO given daily throughout hospitalization for up to 2 years post burn
4	Collection of blood and tissues	Propranolol PO given daily throughout hospitalization for up to 2 years post burn
5	Stable Isotope Infusion Study	Oxandrolone and propranolol PO to be given daily for up to 2 years post burn
2	Collection of blood and tissues	Ketoconazole by mouth (PO) given twice a day throughout hospitalization for up to 2 years post burn
4	Stable Isotope Infusion Study	Propranolol PO given daily throughout hospitalization for up to 2 years post burn
5	Collection of blood and tissues	Oxandrolone and propranolol PO to be given daily for up to 2 years post burn
5	Oxandrolone and propranolol combined	Oxandrolone and propranolol PO to be given daily for up to 2 years post burn
6	Stable Isotope Infusion Study	Humatrope SQ and Propranolol PO to be given daily for up to 2 years post burn
1	Stable Isotope Infusion Study	Humatrope subcutaneous(SQ) 0.05-0.2 mg/kg/day for up to 2 years post burn
7	Stable Isotope Infusion Study	Placebo PO to be given for up to 2 years post burn
7	Placebo	Placebo PO to be given for up to 2 years post burn
9	Stable Isotope Infusion Study	Exercise--home or community based exercise program
2	Stable Isotope Infusion Study	Ketoconazole by mouth (PO) given twice a day throughout hospitalization for up to 2 years post burn
3	Collection of blood and tissues	Oxandrolone PO given daily throughout hospitalization for up to 2 years post burn
6	Collection of blood and tissues	Humatrope SQ and Propranolol PO to be given daily for up to 2 years post burn
8	Stable Isotope Infusion Study	Exercise--hospital supervised intensive exercise program
8	Collection of blood and tissues	Exercise--hospital supervised intensive exercise program
6	Humatrope and propranolol combined	Humatrope SQ and Propranolol PO to be given daily for up to 2 years post burn
7	Collection of blood and tissues	Placebo PO to be given for up to 2 years post burn
8	Exercise--Hospital supervised intensive exercise program	Exercise--hospital supervised intensive exercise program
9	Collection of blood and tissues	Exercise--home or community based exercise program
9	Home exercise program	Exercise--home or community based exercise program
3	Oxandrolone	Oxandrolone PO given daily throughout hospitalization for up to 2 years post burn
4	Propranolol	Propranolol PO given daily throughout hospitalization for up to 2 years post burn

Primary Outcome Measures

Name	Time	Method
Measures of muscle wasting, weakness, immunosuppression chronic bone loss and decreased growth with increases in metabolic, hemodynamic, inflammatory and scarring responses.	Admission to burn unit and up to 2 years post burn and yearly after that	Dual Energy X-Ray Absorptiometry measurements will be utilized to measure muscle wasting

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States