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Glucose Control in Severely Burned Patients

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ClinicalTrials.gov Identifier: NCT01307306
Recruitment Status : Recruiting
First Posted : March 2, 2011
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Marc Jeschke, 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.

Condition or disease Intervention/treatment
Burns Drug: Humulin R Drug: Metformin

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential
Study Start Date : March 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
Drug Information available for: Metformin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Dr. Marc Jeschke, Sunnybrook Health Sciences Centre:
Thermal injury
Chemical Burn
Flame Burn

Additional relevant MeSH terms:
Insulin, Globin Zinc
Metformin
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs