Glucose Control in Severely Burned Patients
- Registration Number
- NCT01307306
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- between 18 and 90 years of age
- >20% TBSA
- Admitted to the burn unit within 120 hours following burn
- At least 1 surgical intervention necessary
- death upon admission
- decision not to treat due to burn injury severity
- presence of anoxic brain injury that is not expected to result in complete recovery
- known history of AIDS, ARC, HIV, Hepatitis B-E
- history of cancer within 5 years of malignancy currently under treatment
- inability to obtain informed consent
- previous or existing renal dysfunction, liver disease, or hepatic dysfunction
- pre-existing type I diabetes mellitus
- pregnancy
- allergy to metformin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin Metformin - Insulin Humulin R -
- Primary Outcome Measures
Name Time Method Perform oral glucose tolerance test 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.
- Secondary Outcome Measures
Name Time Method Measure concentrations of serum cytokines 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 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 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.
Trial Locations
- Locations (1)
Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada