Clinical Trial: Glucose Control in Severely Burned Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential

Brief Summary: The central aim of this application is to determine whether improved outcomes with tight euglycemic control are due to insulin-specific responses. The investigators hypothesize that improving insulin resistance will lead to decreased inflammatory and hypermetabolic responses, as well as restored glucose metabolism, and so result in improved clinical outcome of severely burned patients.

Detailed Summary:
Sponsor: Sunnybrook Health Sciences Centre

Current Primary Outcome:

• Perform oral glucose tolerance test [ Time Frame: at 1-2 months post-admission, up to 6 months ]
  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: assessed at discharge (1-4 months post admission depending on the 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Measure concentrations of serum cytokines [ Time Frame: weekly until discharge (1-4 months post admission depending on severity of injury) ]
  Inflammatory response will be assessed by measuring the concentrations (in 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 sepsis [ Time Frame: daily until discharge (1-4 months post admission depending on severity of injury) ]
  Patients will be assessed daily for episodes of sepsis. The total number of episodes over the course of hospital stay will be recorded.
• Record the episodes of Pneumonia [ Time Frame: daily until discharge (1-4 months post admission depending on severity of injury) ]
  Pneumonia is defined by new progressive and persistent infiltrate, consolidation or cavitations, inhalation injury based on chest X-ray. We will also follow the guidelines provided by the American Burn Association on the definition of Pneumonia in burn patients. Change in sputum (purulent or increased) will also be recorded.

Original Secondary Outcome: Same as current

Information By: Sunnybrook Health Sciences Centre

Dates:
Date Received: January 21, 2011
Date Started: March 2011
Date Completion: September 2019
Last Updated: October 17, 2016
Last Verified: October 2016