Study 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
Fenofibrate and Propranolol in Burn Patients
Mechanisms of Fenofibrate and Propranolol Alone or Combined in Burn Patients
2 other identifiers
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2015
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2019
CompletedNovember 29, 2019
August 1, 2018
3.1 years
May 12, 2015
November 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose Metabolism
Glucose levels and amount of regular insulin infused during hospitalization.
From randomization up to one year
Secondary Outcomes (2)
Hypermetabolism
From randomization up to one year
Rate pressure product
Participants will be followed for the duration of hospital stay, an average of 5 weeks
Study Arms (4)
Fenofibrate
ACTIVE COMPARATORFenofibrate by mouth given daily throughout hospitalization for up to 12 months
Fenofibrate and Propranolol
ACTIVE COMPARATORFenofibrate and Propranolol by mouth given throughout hospitalization for up to 12 months
Placebo
PLACEBO COMPARATORPlacebo by mouth given daily throughout hospitalization for up to 12 months.
Propranolol
ACTIVE COMPARATORPropranolol by mouth given throughout hospitalization for up to 12 months
Interventions
Fenofibrate by mouth given daily throughout hospitalization for up to 12 months
Placebo by mouth given daily throughout hospitalization for up to 12 months
Propranolol by mouth given daily throughout hospitalization for up to 12 months
Eligibility Criteria
You may qualify if:
- through 80 years
- ≥ 20% Total Body Surface Area Burn injury
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shriners Hospitals for Children
Galveston, Texas, 77551, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David N Herndon, MD
University of Texas
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2015
First Posted
May 22, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2018
Study Completion
July 12, 2019
Last Updated
November 29, 2019
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share