Catecholamine Blockade Post-burn
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ClinicalTrials.gov Identifier: NCT01299753 |
Recruitment Status : Unknown
Verified April 2017 by Dr. Marc Jeschke, Sunnybrook Health Sciences Centre.
Recruitment status was: Recruiting
First Posted : February 18, 2011
Last Update Posted : April 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Burns | Drug: placebo Drug: propranolol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Clinical and Molecular Effects of Catecholamine Blockade Post-burn |
Study Start Date : | February 2011 |
Estimated Primary Completion Date : | February 2020 |
Estimated Study Completion Date : | August 2020 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Control |
Drug: placebo
identically packed placebo |
Experimental: Beta blockade |
Drug: propranolol
20-40 mg q6-8h |
- 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.
- Measure concentrations of serum cytokines [ Time Frame: weekly until discharge (1-4 months post admission depending on severity) ]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.
- Record the episodes of Pneumonia [ Time Frame: daily until discharge (1-4 months post admission depending on severity) ]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.
- Record the episodes of sepsis [ Time Frame: daily until discharge (1-4 months post admission depending on severity of injury) ]Patients are evaluated daily and the number of episodes of sepsis or bloodstream infection will be recorded
- 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) ]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.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients between 18 and 90 years of age
- >25% TBSA burn
Exclusion Criteria:
- Death upon admission
- Decision not to treat due to burn injury severity

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299753
Contact: Marc G Jeschke, MD PhD | 416-480-6703 | marc.jeschke@sunnybrook.ca | |
Contact: Marjorie A Burnett, HonsBSc | 416-480-6100 ext 88021 | marjorie.burnett@sunnybrook.ca |
Canada, Ontario | |
Ross Tilley Burn Centre - Sunnybrook HSC | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Marc G Jeschke, MD PhD 416-480-6703 marc.jeschke@sunnybrook.ca | |
Contact: Marjorie Burnett, Hons.BSc 416-480-6100 ext 88021 marjorie.burnett@sunnybrook.ca | |
Sub-Investigator: Gordon Rubenfeld, MD |
Principal Investigator: | Marc G Jeschke, MD PhD | Sunnybrook Health Sciences Centre |
Responsible Party: | Dr. Marc Jeschke, Principal Investigator, Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT01299753 |
Other Study ID Numbers: |
Propran_Jeschke |
First Posted: | February 18, 2011 Key Record Dates |
Last Update Posted: | April 26, 2017 |
Last Verified: | April 2017 |
Burns Wounds and Injuries Propranolol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Vasodilator Agents |