Catecholamine Blockade Post-burn

NCT01299753 | Unknown

• 1 other identifier: Propran_Jeschke
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Measure concentrations of serum cytokines

  weekly until discharge (1-4 months post admission depending on severity)

• Record the episodes of Pneumonia

  daily until discharge (1-4 months post admission depending on severity)

• Record the episodes of sepsis

  daily until discharge (1-4 months post admission depending on severity of injury)

• 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)

Study Arms (2)

Control

PLACEBO COMPARATOR

Drug: placebo

Beta blockade

EXPERIMENTAL

Drug: propranolol

Interventions

placebo DRUG

identically packed placebo

Control

propranolol DRUG

20-40 mg q6-8h

Beta blockade

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 90 years of age
• \>25% TBSA burn

You may not qualify if:

• Death upon admission
• Decision not to treat due to burn injury severity

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Ross Tilley Burn Centre - Sunnybrook HSC

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Burns

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Marc G Jeschke, MD PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: February 18, 2011
• Study Start: February 1, 2011
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

CA (1)