Catecholamine Blockade Post-burn

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Sunnybrook Health Sciences Centre
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 01, 2014