BurnPhase 2/3NCT01902810
Protective Effects of Propranolol in Adults
A Phase 2/3 study testing Propranolol in people with Burn, run by The University of Texas Medical Branch, Galveston at 10 sites in 2 countries.
Trial summary
This efficacy and safety trial will examine the effects and safety of propranolol administered to adult patients with severe burn injury. The investigators hypothesize that propranolol will provide significant benefit to adults following severe burn injury at doses that are safe and do not increase risk of adverse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn
- What is being tested?
- Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jul 2013to 12 Jul 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 20% Total Body Surface Area (TBSA) burn with anticipated operation need on admission
- Age ≥ 18 years
- Admission within 72 hours of injury
Who cannot join
- Age <18
- Patients unlikely to survive injury or with ;age = total burn size ≥ 130
- Electrical or deep chemical burn
- Malignancy currently undergoing treatment or history of cancer treatment within 5 years
- History of HIV or AIDS
- Presence of anoxic brain injury that is not expected to result in complete recovery
Show all 14Show fewer
- Currently treated for Chronic Obstructive Pulmonary Disease (COPD), asthma or other chronic pulmonary conditions
- History of Congestive Heart Failure (CHF) (ejection fraction < 20%)
- Pre-injury medications including blocking agents (alpha or beta) or other anti-arrhythmic drugs
- Pregnant women
- Prisoners
- History of cardiac arrhythmia requiring medication
- Medical condition requiring glucocorticoid treatment
- Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ohio State University
Columbus, Ohio, 43210
University of Texas, Southwestern
Dallas, Texas, 75390
University of Florida
Gainesville, Florida, 32610
University of Texas Medical Branch
Galveston, Texas, 77551
University of Iowa
Iowa City, Iowa, 52242
Loyola University Burn Center
Maywood, Illinois, 60153
Cornell Burn Center
New York, New York, 10065
University of Washington
Seattle, Washington, 98104
About this study
Official title: Protective Effects of Propranolol in Adults Following Major Burn Injury: A Safety and Efficacy Trial
This efficacy and safety trial will examine the effects and safety of propranolol administered to adult patients with severe burn injury. The investigators hypothesize that propranolol will provide significant benefit to adults following severe burn injury at doses that are safe and do not increase risk of adverse infectious and non-infectious outcomes.
Read the detailed description
A safety and efficacy trial is needed in order to determine the safety of propranolol treatment in adult burn patients, identify which subpopulations may be most likely to benefit from propranolol treatment and to identify propranolol dose levels that are not only safe but potentially effective.
- Conditions
- Burn
- Being tested
- Propranolol, Placebo
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called metoprolol, inderol
Propranolol by mouth given daily throughout hospitalization
PlaceboDrug
Also called control
Placebo by mouth given daily throughout hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Active comparator | Propranolol by mouth given daily throughout hospitalization Receives: Drug: Propranolol |
| Sugar Pill | Placebo comparator | Placebo by mouth given daily throughout hospitalization Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac rate pressure product
Multiply the subjects resting heart rate and blood pressure measurements as the average per 24 hours
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes (1)
Mortality rates
mortality rates will be compared between placebo group and propranolol treatment groups
Measured: time of randomization up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2019
- Study completion12 Jul 2019
Why it stopped: At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, American Burn Association
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902810
- Sponsor's protocol ID
- 12-205
- Status last verified
- Aug 2018
- First submitted
- 24 Jun 2013
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effects of Propranolol in Adults Following Major Burn Injury: A Safety and Efficacy Trial
- ClinicalTrials.gov ID
- NCT01902810
- Acronym / sponsor ID
- 12-205
- Conditions
- Burn
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- United States Department of Defense, American Burn Association
- Study start
- Jul 2013 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This efficacy and safety trial will examine the effects and safety of propranolol administered to adult patients with severe burn injury. The investigators hypothesize that propranolol will provide significant benefit to adults following severe burn injury at doses that are safe and do not increase risk of adverse infectious and non-infectious outcomes.
Detailed description
A safety and efficacy trial is needed in order to determine the safety of propranolol treatment in adult burn patients, identify which subpopulations may be most likely to benefit from propranolol treatment and to identify propranolol dose levels that are not only safe but potentially effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Active comparator | Drug: PropranololPropranolol by mouth given daily throughout hospitalization |
| Sugar Pill | Placebo comparator | Drug: PlaceboPlacebo by mouth given daily throughout hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 20% Total Body Surface Area (TBSA) burn with anticipated operation need on admission
- Age ≥ 18 years
- Admission within 72 hours of injury
Key exclusion criteria (14 listed)
- Age <18
- Patients unlikely to survive injury or with ;age = total burn size ≥ 130
- Electrical or deep chemical burn
- Malignancy currently undergoing treatment or history of cancer treatment within 5 years
- History of HIV or AIDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololAlso: metoprolol, inderolPropranolol by mouth given daily throughout hospitalization | Drug | Propranolol |
| PlaceboAlso: controlPlacebo by mouth given daily throughout hospitalization | Drug | Sugar Pill |
Primary outcome
Cardiac rate pressure product
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Multiply the subjects resting heart rate and blood pressure measurements as the average per 24 hours
1 secondary outcome
Mortality rates
Time frame: time of randomization up to one year
Results and safety
The study was stopped early (reason given: At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David N Herndon, MD principal investigator
University of Texas
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propranolol in people with Burn, run by The University of Texas Medical Branch, Galveston at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac rate pressure product (time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.