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NCT Number: NCT04530058

The Effects of Metformin on Morbidity and Mortality in Elderly Patients

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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Key information

Conditions

Burns Wounds and Injuries

Age range

60 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hamilton Health Sciences Centre

Hamilton, Ontario, L8L 2X2, Canada

Location contact

Marc G. Jeschke, MD PhD

CONTACT

[email protected]

905-521-2100 ext. 40694

Marc G. Jeschke, MD PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 60 - 99 years of age.
  • ≥5% total body surface area (TBSA) burn.
  • Admitted to burn center ≤ 120 hours post-burn injury.
  • At least one surgical intervention likely required.
  • 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.
  • Pre-existing renal failure (eGFR is < 30 mL/min).
  • Severe liver disease (Child-Pugh C).
  • 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.

Treatment and study plan

metformin

Drug

Metformin 500 mg twice a day, administered orally or via gastric tube.

Placebos

Drug

Placebo twice a day, administered orally or via gastric tube.

Primary outcomes

  1. Record mortality

    Time frame: Acute hospitalization up to one year post burn.

    Patient mortality will be recorded during hospitalization and outpatient follow-ups.

  2. 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.

  3. Record episodes of infection.

    Time frame: 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.

  4. Record episodes of pneumonia.

    Time frame: 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.

  5. Organ function - Alkaline phosphatase (ALP)

    Time frame: 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).

  6. Organ function - Alanine transaminase (ALT)

    Time frame: 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).

  7. Organ function - Bilirubin

    Time frame: 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).

  8. Organ function - Blood Urea Nitrogen (BUN)

    Time frame: twice weekly until discharge (1-4 months post admission depending on severity of injury)]

    Organ function will be assessed by measuring the biomarker: BUN (mmol).

  9. Organ function - Creatinine

    Time frame: 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 outcomes

  1. Measures of steady-state resting energy expenditure (REE)

    Time frame: 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.

  2. Perform oral glucose tolerance test

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc G Jeschke, MD PhD

CONTACT

[email protected]

905-521-2100 ext. 40694

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

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

Acronym: MET-ELD

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Aug 28, 2020
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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