The Effects of Metformin on Morbidity and Mortality in Elderly Patients

Burns Clinical Trial

— MET-ELD  

Official title:

The Effects of Metformin on Morbidity and Mortality in Elderly Patients- a Prospective Randomized Control Trial (RCT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04530058
• Other study ID #: 15230
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2024
• Est. completion date: March 2029

Study information

• Verified date: December 2023
• Source: Hamilton Health Sciences Corporation
• Contact: Marc G Jeschke, MD PhD
• Phone: 905-521-2100
• Email: marc.jeschke[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: March 2029
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Aged 60 - 99 years of age.

2. =5% total body surface area (TBSA) burn.

3. Admitted to burn center = 120 hours post-burn injury.

4. At least one surgical intervention likely required.

5. Provide written informed consent.

Exclusion Criteria:

1. Death upon admission.

2. Decision not to treat due to burn injury severity.

3. Presence of anoxic brain injury that is not expected to result in complete recovery.

4. Pre-existing renal failure (eGFR is < 30 mL/min).

5. Severe liver disease (Child-Pugh C).

6. Pre-existing insulin-dependent type II diabetes.

7. Clinical contraindication to give metformin.

8. Allergy to metformin or insulin.

9. History of lactic acidosis while receiving metformin treatment.

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Metformin
Metformin 500 mg twice a day, administered orally or via gastric tube.
• Placebos
Placebo twice a day, administered orally or via gastric tube.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Record mortality	Patient mortality will be recorded during hospitalization and outpatient follow-ups.	Acute hospitalization up to one year post burn.
Primary	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)]
Primary	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)]
Primary	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)]
Primary	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)]
Primary	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)]
Primary	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)]
Primary	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)]
Primary	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)]
Secondary	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)]
Secondary	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)]