The Effects of Metformin on Morbidity and Mortality in Elderly Patients

NCT04530058 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 15230
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (9)

• 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)]

• 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)]

Secondary Outcomes (2)

• 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)]

• Perform oral glucose tolerance test

  once at discharge from hospital (1-4 months post admission depending on the severity of injury)]

Study Arms (2)

Control

PLACEBO COMPARATOR

Drug: Placebos

Metformin

EXPERIMENTAL

Drug: Metformin

Interventions

Metformin DRUG

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

Metformin

Placebos DRUG

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

Control

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences Centre

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Burns

Interventions

Metformin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Marc G Jeschke, MD PhD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc G Jeschke, MD PhD

CONTACT

905-521-2100; marc.jeschke@hhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 28, 2020
• Study Start: November 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)