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Elderly patients have an increased susceptibility to burns and a substantial mortality that has not significantly changed over the last three decades. Elderly burn patients not only have an augmented response to burn but also express a prolonged hypermetabolic response.Glucose metabolism with insulin resistance is a hypermetabolic response pathway that profoundly affects post-burn outcomes. The aim if this study is to determine whether metformin can improve morbidity and mortality in elderly burn patients. The investigators hypothesize that metformin will improve clinical outcomes and mortality of elderly burn patients by alleviating the complex inflammatory and hypermetabolic responses after burn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator |
| |
| Metformin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin 500 mg twice a day, administered orally or via gastric tube. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Record mortality | Patient mortality will be recorded during hospitalization and outpatient follow-ups. | Acute hospitalization up to one year post burn. |
| Record the episodes of sepsis. | Patients will be assessed daily for episodes of sepsis. The total number of episodes over the course of hospital stay will be recorded. | daily until discharge (1-4 months post admission depending on severity of injury)] |
| Record episodes of infection. | Patients will be assessed daily for episodes of infection. The total number of episodes over the course of hospital stay will be recorded. | daily until discharge (1-4 months post admission depending on severity of injury)] |
| Record episodes of pneumonia. | Patients will be assessed daily for episodes of infection. The total number of episodes over the course of hospital stay will be recorded. | daily until discharge (1-4 months post admission depending on severity of injury)] |
| Organ function - Alkaline phosphatase (ALP) | Organ function will be assessed by measuring the biomarker: ALP (U/L). | twice weekly until discharge (1-4 months post admission depending on severity of injury)] |
| Organ function - Alanine transaminase (ALT) | Organ function will be assessed by measuring the biomarker: ALT (U/L). | twice weekly until discharge (1-4 months post admission depending on severity of injury)] |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of steady-state resting energy expenditure (REE) | Metabolic response to injury and illness can be studied by measuring steady-state resting energy expenditure. Hypermetabolism is used as a secondary endpoint as stress-induced diabetes is associated with inflammation and hypermetabolism. | weekly until discharge if a patient is intubated and ventilated (1-4 months post admission depending on severity of injury)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc G Jeschke, MD PhD | Contact | 905-521-2100 | 40694 | marc.jeschke@hhsc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Marc G Jeschke, MD PhD | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences Centre | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebos |
| Drug |
Placebo twice a day, administered orally or via gastric tube. |
|
| Organ function - Bilirubin |
Organ function will be assessed by measuring the biomarker: bilirubin (umol). |
| twice weekly until discharge (1-4 months post admission depending on severity of injury)] |
| Organ function - Blood Urea Nitrogen (BUN) | Organ function will be assessed by measuring the biomarker: BUN (mmol). | twice weekly until discharge (1-4 months post admission depending on severity of injury)] |
| Organ function - Creatinine | Organ function will be assessed by measuring the biomarker: creatinine (umol/L). | twice weekly until discharge (1-4 months post admission depending on severity of injury)] |
| Perform oral glucose tolerance test | 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. | once at discharge from hospital (1-4 months post admission depending on the severity of injury)] |