Clinical trial NCT04530058: The Effects of Metformin on Morbidity and Mortality in Elderly Patients
Official title: The Effects of Metformin on Morbidity and Mortality in Elderly Patients- a Prospective Randomized Control Trial (RCT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Burns
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Record mortality
timeFrame: Acute hospitalization up to one year post burn.
measure: Record the episodes of sepsis.
timeFrame: daily until discharge (1-4 months post admission depending on severity of injury)]
measure: Record episodes of infection.
timeFrame: daily until discharge (1-4 months post admission depending on severity of injury)]
measure: Record episodes of pneumonia.
timeFrame: daily until discharge (1-4 months post admission depending on severity of injury)]
measure: Organ function - Alkaline phosphatase (ALP)
timeFrame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
measure: Organ function - Alanine transaminase (ALT)
timeFrame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
measure: Organ function - Bilirubin
timeFrame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
measure: Organ function - Blood Urea Nitrogen (BUN)
timeFrame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
measure: Organ function - Creatinine
timeFrame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Secondary outcomes:
measure: Measures of steady-state resting energy expenditure (REE)
timeFrame: weekly until discharge if a patient is intubated and ventilated (1-4 months post admission depending on severity of injury)]
measure: Perform oral glucose tolerance test
timeFrame: once at discharge from hospital (1-4 months post admission depending on the severity of injury)]
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Marc G Jeschke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: