search
Back to results

Catecholamine Blockade Post-burn

Primary Purpose

Burns

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
placebo
propranolol
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ross Tilley Burn Centre - Sunnybrook HSC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Beta blockade

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
Record the episodes of sepsis
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
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.

Full Information

First Posted
January 24, 2011
Last Updated
March 24, 2022
Sponsor
Sunnybrook Health Sciences Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT01299753
Brief Title
Catecholamine Blockade Post-burn
Official Title
Clinical and Molecular Effects of Catecholamine Blockade Post-burn
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Beta blockade
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
identically packed placebo
Intervention Type
Drug
Intervention Name(s)
propranolol
Intervention Description
20-40 mg q6-8h
Primary Outcome Measure Information:
Title
Perform oral glucose tolerance test
Description
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.
Time Frame
Conduct at week 1 post admission
Title
Perform oral glucose tolerance test
Description
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.
Time Frame
Conduct at week 3 post admission
Title
Perform oral glucose tolerance test
Description
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.
Time Frame
Conduct at discharge (1-4 months post admission depending on severity of injury)
Secondary Outcome Measure Information:
Title
Measure concentrations of serum cytokines
Description
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.
Time Frame
weekly until discharge (1-4 months post admission depending on severity)
Title
Record the episodes of Pneumonia
Description
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.
Time Frame
daily until discharge (1-4 months post admission depending on severity)
Title
Record the episodes of sepsis
Description
Patients are evaluated daily and the number of episodes of sepsis or bloodstream infection will be recorded
Time Frame
daily until discharge (1-4 months post admission depending on severity of injury)
Title
Measure the levels of activated signaling proteins using protein blotting
Description
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.
Time Frame
assess at 1st operation (week 1-2 post admission on average) and 3rd operation (week 3-4 post admission on average)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc G Jeschke, MD PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ross Tilley Burn Centre - Sunnybrook HSC
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Catecholamine Blockade Post-burn

We'll reach out to this number within 24 hrs