BurnsNCT01299753
Catecholamine Blockade Post-burn
A study testing propranolol in people with Burns, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Severe burn is associated with a wide array of stress, metabolic, and physiologic processes in an attempt to restore homeostasis. The catecholamine induced stress response following severe burns is particularly exaggerated and manifests detrimentally as inflammation, insulin resistance, hypermetabolism, and associated… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Burns
- What is being tested?
- propranolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to 31 Dec 2023
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 90 years of age
- >25% TBSA burn
Who cannot join
- Death upon admission
- Decision not to treat due to burn injury severity
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ross Tilley Burn Centre - Sunnybrook HSC
Toronto, Ontario, M4N 3M5
About this study
Official title: Clinical and Molecular Effects of Catecholamine Blockade Post-burn
Severe burn is associated with a wide array of stress, metabolic, and physiologic processes in an attempt to restore homeostasis. The catecholamine induced stress response following severe burns is particularly exaggerated and manifests detrimentally as inflammation, insulin resistance, hypermetabolism, and associated profound protein catabolism. The investigators hypothesize that catecholamine blockade will lead to restored IR signaling and result in improved post-burn morbidity. The investigators will further determine the molecular mechanisms mediating these effects.
- Conditions
- Burns
- Being tested
- placebo, propranolol
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
identically packed placebo
propranololDrug
20-40 mg q6-8h
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Drug: placebo |
| Beta blockade | Experimental | Not described Receives: Drug: propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perform oral glucose tolerance test
Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.
Measured: Conduct at week 1 post admission
Perform oral glucose tolerance test
Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.
Measured: Conduct at week 3 post admission
Perform oral glucose tolerance test
Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.
Measured: Conduct at discharge (1-4 months post admission depending on severity of injury)
Secondary outcomes (4)
Measure concentrations of serum cytokines
Inflammatory response will be assessed by measuring the concentrations (pg/ml) of a panel of serum cytokines (IL-1, IFN, TNF etc.) using the Bio-Plex 17-Plex Suspension assay.
Measured: weekly until discharge (1-4 months post admission depending on severity)
Record the episodes of Pneumonia
Pneumonia is defined by the following criteria: new progressive and persistent infiltrate, consolidation, or cavitations, in light of the baseline evaluation for inhalational injury on chest X-ray, along with signs of sepsis, worsening gas exchange (decreased P/F ratio), increased O2, and change in the sputum, e.g. purulent or increased sputum production.
Measured: daily until discharge (1-4 months post admission depending on severity)
Record the episodes of sepsis
Patients are evaluated daily and the number of episodes of sepsis or bloodstream infection will be recorded
Measured: daily until discharge (1-4 months post admission depending on severity of injury)
Measure the levels of activated signaling proteins using protein blotting
The level of activation of a protein signaling cascade (fold change compared to control), as indicated by the amount of phosphorylated protein substrates (e.g. p-Akt/Akt), will be measured in tissue obtained at operation using protein blotting techniques in the laboratory.
Measured: assess at 1st operation (week 1-2 post admission on average) and 3rd operation (week 3-4 post admission on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marc Jeschke, Sunnybrook Health Sciences Centre
- Investigators
- Marc G Jeschke, MD PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299753
- Sponsor's protocol ID
- Propran_Jeschke
- Status last verified
- Mar 2022
- First submitted
- 24 Jan 2011
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Effects of Catecholamine Blockade Post-burn
- ClinicalTrials.gov ID
- NCT01299753
- Acronym / sponsor ID
- Propran_Jeschke
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Feb 2011 (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.
Severe burn is associated with a wide array of stress, metabolic, and physiologic processes in an attempt to restore homeostasis. The catecholamine induced stress response following severe burns is particularly exaggerated and manifests detrimentally as inflammation, insulin resistance, hypermetabolism, and associated profound protein catabolism. The investigators hypothesize that catecholamine blockade will lead to restored IR signaling and result in improved post-burn morbidity. The investigators will further determine the molecular mechanisms mediating these effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: placebo |
| Beta blockade | Experimental | Drug: propranolol |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between 18 and 90 years of age
- >25% TBSA burn
Key exclusion criteria (2 listed)
- Death upon admission
- Decision not to treat due to burn injury severity
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 |
|---|---|---|
| placeboidentically packed placebo | Drug | Control |
| propranolol20-40 mg q6-8h | Drug | Beta blockade |
Primary outcome
Perform oral glucose tolerance test
Time frame: Conduct at week 1 post admission
Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.
Perform oral glucose tolerance test
Time frame: Conduct at week 3 post admission
Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.
Perform oral glucose tolerance test
Time frame: Conduct at discharge (1-4 months post admission depending on severity of injury)
Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.
4 secondary outcomes
Measure concentrations of serum cytokines
Time frame: weekly until discharge (1-4 months post admission depending on severity)
Record the episodes of Pneumonia
Time frame: daily until discharge (1-4 months post admission depending on severity)
Record the episodes of sepsis
Time frame: daily until discharge (1-4 months post admission depending on severity of injury)
Measure the levels of activated signaling proteins using protein blotting
Time frame: assess at 1st operation (week 1-2 post admission on average) and 3rd operation (week 3-4 post admission on average)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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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.
Marc G Jeschke, MD PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propranolol in people with Burns, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
Are results available for this study?
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?
Perform oral glucose tolerance test (time frame: Conduct at week 1 post admission). The study lists 3 primary outcomes in all. 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 28 Mar 2022.