Catecholamine Blockade Post-burn
This study is currently recruiting participants.
Verified January 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Dr. Marc Jeschke, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01299753
First received: January 24, 2011
Last updated: January 29, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Burns |
Drug: placebo Drug: propranolol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Clinical and Molecular Effects of Catecholamine Blockade Post-burn |
Resource links provided by NLM:
Further study details as provided by Sunnybrook Health Sciences Centre:
Primary Outcome Measures:
- Perform oral glucose tolerance test [ Time Frame: Conduct at week 1 post admission ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Measure concentrations of serum cytokines [ Time Frame: weekly until discharge (1-4 months post admission depending on severity) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Control |
Drug: placebo
identically packed placebo
|
| Experimental: Beta blockade |
Drug: propranolol
20-40 mg q6-8h
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299753
Contacts
| 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 |
Locations
| 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 | |
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
| Principal Investigator: | Marc G Jeschke, MD PhD | Sunnybrook Health Sciences Centre |
More Information
No publications provided
| Responsible Party: | Dr. Marc Jeschke, Principal Investigator, Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT01299753 History of Changes |
| Other Study ID Numbers: | Propran_Jeschke |
| Study First Received: | January 24, 2011 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries Propranolol Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents |
ClinicalTrials.gov processed this record on May 23, 2013