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Fenofibrate and Propranolol in Burn Patients

Primary Purpose

Burn

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fenofibrate

Placebo

Propranolol

About this trial

This is an interventional treatment trial for Burn

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

0 through 80 years
≥ 20% Total Body Surface Area Burn injury

Exclusion Criteria:

Pregnancy

History or existence of pre-burn injury conditions

Allergies to propranolol or fenofibrate
Asthma requiring treatment
Congestive heart failure (measured ejection fraction < 20%)
Renal or hepatic disease
Medical condition requiring glucocorticoid treatment
History of AIDS, Aids Related Complex or HIV
History of Cancer within 5 years

Decision not to treat due to burn injury severity or futility as deemed by the clinical team

Sites / Locations

Shriners Hospitals for Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Fenofibrate

Fenofibrate and Propranolol

Placebo

Propranolol

Arm Description

Fenofibrate by mouth given daily throughout hospitalization for up to 12 months

Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months

Placebo by mouth given daily throughout hospitalization for up to 12 months.

Propranolol by mouth given throughout hospitalization for up to 12 months

Outcomes

Primary Outcome Measures

Glucose Metabolism

Glucose levels and amount of regular insulin infused during hospitalization.

Secondary Outcome Measures

Hypermetabolism

Resting energy expenditure (REE) done weekly while in hospital

Rate pressure product

Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized

Full Information

NCT ID

NCT02452255

First Posted

May 12, 2015

Last Updated

November 26, 2019

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

National Institute of General Medical Sciences (NIGMS), Shriners Hospitals for Children

1. Study Identification

Unique Protocol Identification Number

NCT02452255

Brief Title

Fenofibrate and Propranolol in Burn Patients

Official Title

Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

Shriner's Burn Hospital closed the study and access to study-related data is unavailable. We are unable to submit the additional information or results-data

Study Start Date

November 2015 (undefined)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

National Institute of General Medical Sciences (NIGMS), Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate plus propranolol have therapeutic, physiological, and metabolic effects that will improve clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.

Detailed Description

Determine the clinical benefits and underlying mechanisms whereby the metabolic perturbators fenofibrate and propranolol impact burn patient outcomes. The investigators hypothesize that these metabolic regulators given for one year will maintain body mass, improve muscle function by increasing protein synthesis, augment wound healing, reduce fibrosis, improve cardiovascular function, reduce systemic inflammation, restore insulin sensitivity, and decrease liver dysfunction without the risk of the hypoglycemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fenofibrate

Arm Type

Active Comparator

Arm Description

Fenofibrate by mouth given daily throughout hospitalization for up to 12 months

Arm Title

Fenofibrate and Propranolol

Arm Type

Active Comparator

Arm Description

Fenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo by mouth given daily throughout hospitalization for up to 12 months.

Arm Title

Propranolol

Arm Type

Active Comparator

Arm Description

Propranolol by mouth given throughout hospitalization for up to 12 months

Intervention Type

Drug

Intervention Name(s)

Fenofibrate

Other Intervention Name(s)

Tricor

Intervention Description

Fenofibrate by mouth given daily throughout hospitalization for up to 12 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Control

Intervention Description

Placebo by mouth given daily throughout hospitalization for up to 12 months

Intervention Type

Drug

Intervention Name(s)

Propranolol

Other Intervention Name(s)

Metoprolol, inderal

Intervention Description

Propranolol by mouth given daily throughout hospitalization for up to 12 months

Primary Outcome Measure Information:

Title

Glucose Metabolism

Description

Glucose levels and amount of regular insulin infused during hospitalization.

Time Frame

From randomization up to one year

Secondary Outcome Measure Information:

Title

Hypermetabolism

Description

Resting energy expenditure (REE) done weekly while in hospital

Time Frame

From randomization up to one year

Title

Rate pressure product

Description

Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized

Time Frame

Participants will be followed for the duration of hospital stay, an average of 5 weeks

10. Eligibility

Sex

All

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 0 through 80 years ≥ 20% Total Body Surface Area Burn injury Exclusion Criteria: Pregnancy History or existence of pre-burn injury conditions Allergies to propranolol or fenofibrate Asthma requiring treatment Congestive heart failure (measured ejection fraction < 20%) Renal or hepatic disease Medical condition requiring glucocorticoid treatment History of AIDS, Aids Related Complex or HIV History of Cancer within 5 years Decision not to treat due to burn injury severity or futility as deemed by the clinical team

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David N Herndon, MD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shriners Hospitals for Children

City

Galveston

State/Province

Texas

ZIP/Postal Code

77551

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Fenofibrate and Propranolol in Burn Patients

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