Catecholamine Blockade Post-burn

Burns Clinical Trial

Official title:

Clinical and Molecular Effects of Catecholamine Blockade Post-burn

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01299753
• Other study ID #: Propran_Jeschke
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2011
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• placebo
identically packed placebo
• propranolol
20-40 mg q6-8h

Locations

Country	Name	City	State
Canada	Ross Tilley Burn Centre - Sunnybrook HSC	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Conduct at week 1 post admission
Primary	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.	Conduct at week 3 post admission
Primary	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.	Conduct at discharge (1-4 months post admission depending on severity of injury)
Secondary	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.	weekly until discharge (1-4 months post admission depending on severity)
Secondary	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.	daily until discharge (1-4 months post admission depending on severity)
Secondary	Record the episodes of sepsis	Patients are evaluated daily and the number of episodes of sepsis or bloodstream infection will be recorded	daily until discharge (1-4 months post admission depending on severity of injury)
Secondary	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.	assess at 1st operation (week 1-2 post admission on average) and 3rd operation (week 3-4 post admission on average)