Glucose Control in Severely Burned Patients
This study is currently recruiting participants.
Verified January 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Dr. Marc Jeschke, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01307306
First received: January 21, 2011
Last updated: January 29, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Burns |
Drug: Humulin R Drug: Metformin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential |
Resource links provided by NLM:
Further study details as provided by Sunnybrook Health Sciences Centre:
Primary Outcome Measures:
- Perform oral glucose tolerance test [ Time Frame: at 1-2 months post-admission, up to 6 months ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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:
- Measure concentrations of serum cytokines [ Time Frame: weekly until discharge (1-4 months post admission depending on severity of injury) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Metformin |
Drug: Metformin
Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.
|
| Experimental: Insulin |
Drug: Humulin R
Humulin R (U-100) will be given i.v. The dose given will be adjusted in order to achieve a blood glucose level of 130-140 mg/dl.
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307306
Contacts
| Contact: Marc G Jeschke, MD PhD | 416-480-6703 | marc.jeschke@sunnybrook.ca |
| Contact: Marjorie A Burnett, HonsBSc | 416-480-6100 ext 88021 | marjorie.burnett@sunnybrook.ca |
Locations
| Canada, Ontario | |
| Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Marc G Jeschke, MD PhD 416-480-6703 marc.jeschke@sunnybrook.ca | |
| Contact: Marjorie Burnett, HonsBSc 416-480-6100 ext 88021 marjorie.burnett@sunnybrook.ca | |
| Sub-Investigator: Robert Cartotto, MD | |
| Sub-Investigator: Shahriar Shahrokhi, MD | |
| Sub-Investigator: Alison Cheung, PhD | |
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
| Principal Investigator: | Marc G Jeschke, MD PhD | Sunnybrook Health Sciences Centre |
More Information
No publications provided
| Responsible Party: | Dr. Marc Jeschke, Principal Investigator, Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT01307306 History of Changes |
| Other Study ID Numbers: | ins_met_jeschke |
| Study First Received: | January 21, 2011 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Sunnybrook Health Sciences Centre:
|
Thermal injury Chemical Burn Flame Burn |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries Insulin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013