BurnPhase 2/3NCT01957449
Propranolol in Severely Burned Children
A Phase 2/3 study testing Propranolol in people with Burn, run by The University of Texas Medical Branch, Galveston at 4 sites in United States.
Trial summary
To determine the safety and efficacy of administration of propranolol for reducing heart rate and blood pressure in burn injury. Read more about this study
- Who is it for?
- Ages Up to 18 years
- 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
- 63 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2013to 23 Apr 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Burns covering >20% of the total body surface are
- Age of 0 to 18 years
- Patient arrival to the burn center within 96 hours (4 days) of burn injury
- Require > 1 surgical procedure
Who cannot join
- Pregnancy
- Known history of AIDS, Aids Related Complex, or HIV
- History of cancer within 5 years
- Existence of pre-morbid conditions
- Asthma
- Congestive heart failure (measured ejection fraction < 20%)
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- Medical condition requiring glucocorticoid treatment
- Burn injury due to chemical burns
- Burn injury due to deep electrical injury (decision of hospital PI)
- Presence of anoxic brain injury that is not expected to result in complete recovery
- Decision not to treat due to burn injury severity
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Shriners Hospitals for Children
Boston, Massachusetts, 02114
Shriners Hospitals for Children
Cincinnati, Ohio, 45229
Shriners Hospitals for Children
Galveston, Texas, 77551
Shriners Hospitals for Children
Sacramento, California, 95817
About this study
Official title: Safety and Efficacy of Propranolol in Severely Burned Children
To determine the safety and efficacy of administration of propranolol for reducing heart rate and blood pressure in burn injury.
Read the detailed description
Other purposes of this study are to study the effect on muscle function, the infectious process, sepsis, systemic inflammation and long-term scarring. Quality of life will also be looked at over time.
- 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, inderal
Propranolol by mouth given daily throughout hospitalization for up to 12 months
PlaceboDrug
Also called Control
Placebo by mouth given daily throughout hospitalization for up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Active comparator | Propranolol by mouth given daily throughout hospitalization for up to 12 months Receives: Drug: Propranolol |
| Sugar Pill | Placebo comparator | Placebo by mouth given daily throughout hospitalization for up to 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product
Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized (an average of 4 weeks)
Measured: Measured during acute hospital stay, an average of 4 weeks.
Secondary outcomes (1)
Number of deaths
Number of deaths 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 posted8 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2018
- Study completion23 Apr 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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957449
- Sponsor's protocol ID
- 13-103
- Status last verified
- Aug 2018
- First submitted
- 4 Sep 2013
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Propranolol in Severely Burned Children
- ClinicalTrials.gov ID
- NCT01957449
- Acronym / sponsor ID
- 13-103
- 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
- 63 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 8 Oct 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.
To determine the safety and efficacy of administration of propranolol for reducing heart rate and blood pressure in burn injury.
Detailed description
Other purposes of this study are to study the effect on muscle function, the infectious process, sepsis, systemic inflammation and long-term scarring. Quality of life will also be looked at over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Active comparator | Drug: PropranololPropranolol by mouth given daily throughout hospitalization for up to 12 months |
| Sugar Pill | Placebo comparator | Drug: PlaceboPlacebo by mouth given daily throughout hospitalization for up to 12 months |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Burns covering >20% of the total body surface are
- Age of 0 to 18 years
- Patient arrival to the burn center within 96 hours (4 days) of burn injury
- Require > 1 surgical procedure
Key exclusion criteria (11 listed)
- Pregnancy
- Known history of AIDS, Aids Related Complex, or HIV
- History of cancer within 5 years
- Existence of pre-morbid conditions
- Asthma
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, inderalPropranolol by mouth given daily throughout hospitalization for up to 12 months | Drug | Propranolol |
| PlaceboAlso: ControlPlacebo by mouth given daily throughout hospitalization for up to 12 months. | Drug | Sugar Pill |
Primary outcome
Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product
Time frame: Measured during acute hospital stay, an average of 4 weeks.
Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized (an average of 4 weeks)
1 secondary outcome
Number of deaths
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 24 Sep 2019.
- Individual participant dataSharing planned: No
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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
4 sites in 1 country: 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 4 sites in United States.
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 4 inclusion and 11 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product (time frame: Measured during acute hospital stay, an average of 4 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 24 Sep 2019.