The Effects of Metformin on Morbidity and Mortality in Elderly Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Control
|
Drug: Placebos
Placebo twice a day, administered orally or via gastric tube.
|
| Experimental: Metformin
|
Drug: Metformin
Metformin 500 mg twice a day, administered orally or via gastric tube.
|
Outcome Measures
Primary Outcome Measures
- Record mortality [Acute hospitalization up to one year post burn.]
Patient mortality will be recorded during hospitalization and outpatient follow-ups.
- Record the episodes of sepsis. [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 episodes of infection. [daily until discharge (1-4 months post admission depending on severity of injury)]]
Patients will be assessed daily for episodes of infection. The total number of episodes over the course of hospital stay will be recorded.
- Record episodes of pneumonia. [daily until discharge (1-4 months post admission depending on severity of injury)]]
Patients will be assessed daily for episodes of infection. The total number of episodes over the course of hospital stay will be recorded.
- Organ function - ALP [twice weekly until discharge (1-4 months post admission depending on severity of injury)]]
Organ function will be assessed by measuring the biomarker: ALP (U/L).
- Organ function - ALT [twice weekly until discharge (1-4 months post admission depending on severity of injury)]]
Organ function will be assessed by measuring the biomarker: ALT (U/L).
- Organ function - Bilirubin [twice weekly until discharge (1-4 months post admission depending on severity of injury)]]
Organ function will be assessed by measuring the biomarker: bilirubin (umol).
- Organ function - BUN [twice weekly until discharge (1-4 months post admission depending on severity of injury)]]
Organ function will be assessed by measuring the biomarker: blood urea nitrogen (BUN) (mmol).
- Organ function - Creatinine [twice weekly until discharge (1-4 months post admission depending on severity of injury)]]
Organ function will be assessed by measuring the biomarker: creatinine (umol/L).
Secondary Outcome Measures
- Measures of steady-state resting energy expenditure (REE) [weekly until discharge if a patient is intubated and ventilated (1-4 months post admission depending on severity of injury)]]
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.
- Perform oral glucose tolerance test [once at discharge from hospital (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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged 60 - 99 years of age.
-
≥5% TBSA burn.
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Admitted to burn center ≤ 120 hours post-burn injury.
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At least one surgical intervention likely required.
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Provide written informed consent.
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.
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Pre-existing renal failure (eGFR is < 30 mL/min).
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Severe liver disease (Child-Pugh C).
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Pre-existing insulin-dependent type II diabetes.
-
Clinical contraindication to give metformin.
-
Allergy to metformin or insulin.
-
History of lactic acidosis while receiving metformin treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
Investigators
- Principal Investigator: Marc G Jeschke, MD PhD, Sunnybrook Health Sciences Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 237-2016