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
|Condition or disease||Intervention/treatment||Phase|
|Burns||Drug: Humulin R Drug: Metformin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.
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|
- 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.
- 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.
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
|Contact: Marc G Jeschke, MD PhDfirstname.lastname@example.org|
|Contact: Marjorie A Burnett, HonsBSc||416-480-6100 ext email@example.com|
|Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Marc G Jeschke, MD PhD 416-480-6703 firstname.lastname@example.org|
|Contact: Marjorie Burnett, HonsBSc 416-480-6100 ext 88021 email@example.com|
|Sub-Investigator: Robert Cartotto, MD|
|Sub-Investigator: Shahriar Shahrokhi, MD|
|Sub-Investigator: Alison Cheung, PhD|
|Principal Investigator:||Marc G Jeschke, MD PhD||Sunnybrook Health Sciences Centre|