Glucose Control in Severely Burned Patients | RxWiki

Glucose Control in Severely Burned Patients

Overview[ - collapse ][ - ]

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	Burns
Intervention	Drug: Humulin R Drug: Metformin
Phase	N/A
Sponsor	Sunnybrook Health Sciences Centre
Responsible Party	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier	NCT01307306
First Received	January 21, 2011
Last Updated	January 29, 2013
Last verified	January 2013

Tracking Information[ + expand ][ + ]

First Received Date	January 21, 2011
Last Updated Date	January 29, 2013
Start Date	March 2011
Estimated Primary Completion Date	September 2013
Current 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.
Current 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.

Descriptive Information[ + expand ][ + ]

Brief Title	Glucose Control in Severely Burned Patients
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 Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Condition	Burns
Intervention	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. Drug: Metformin Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.
Study Arm (s)	Experimental: Metformin Experimental: Insulin No Intervention: Control

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	60
Estimated Completion Date	September 2013
Estimated Primary Completion Date	March 2013
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Marc G Jeschke, MD PhD 416-480-6703 marc.jeschke@sunnybrook.ca
Location Countries	Canada

Administrative Information[ + expand ][ + ]

NCT Number	NCT01307306
Other Study ID Numbers	ins_met_jeschke
Has Data Monitoring Committee	No
Information Provided By	Sunnybrook Health Sciences Centre
Study Sponsor	Sunnybrook Health Sciences Centre
Collaborators	Not Provided
Investigators	Principal Investigator: Marc G Jeschke, MD PhD Sunnybrook Health Sciences Centre
Verification Date	January 2013

Locations[ + expand ][ + ]

Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre	Toronto, Ontario, Canada, M4N 3M5 Contact: Marc G Jeschke, MD PhD \| 416-480-6703 \| marc.jeschke@sunnybrook.ca Sub-Investigator: Robert Cartotto, MD Recruiting