Catecholamine Blockade Post-burn

Not Applicable

• Conditions: Burns
• Interventions: Drug: propranolol; Drug: placebo

• Registration Number: NCT01299753
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-24
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beta blockade	propranolol	-
Control	placebo	-

Primary Outcome Measures

Name	Time	Method
Perform oral glucose tolerance test	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.

Secondary Outcome Measures

Name	Time	Method
Record the episodes of sepsis	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 concentrations of serum cytokines	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.
Measure the levels of activated signaling proteins using protein blotting	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.
Record the episodes of Pneumonia	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.

Trial Locations

Locations (1)

Ross Tilley Burn Centre - Sunnybrook HSC; 🇨🇦 Toronto, Ontario, Canada