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Completed

NCT Number: NCT01307306

Glucose Control in Severely Burned Patients

The central aim of this application is to determine whether improved outcomes with tight euglycemic control are due to insulin-specific responses. The investigators hypothesize that improving insulin resistance will lead to decreased inflammatory and hypermetabolic responses, as well as restored glucose metabolism, and so result in improved clinical outcome of severely burned patients.

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Key information

Conditions

Burns Burns, Chemical Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • between 18 and 90 years of age
  • >20% TBSA
  • Admitted to the burn unit within 120 hours following burn
  • At least 1 surgical intervention necessary

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
  • known history of AIDS, ARC, HIV, Hepatitis B-E
  • history of cancer within 5 years of malignancy currently under treatment
  • inability to obtain informed consent
  • previous or existing renal dysfunction, liver disease, or hepatic dysfunction
  • pre-existing type I diabetes mellitus
  • pregnancy
  • allergy to metformin

Treatment and study plan

Humulin R

Drug

Humulin R (U-100) will be given i.v. The dose given will be adjusted in order to achieve a blood glucose level of 130-140 mg/dl.

metformin

Drug

Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.

Primary outcomes

  1. Perform oral glucose tolerance test

    Time frame: at 1-2 months post-admission, up to 6 months

    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.

  2. Perform oral glucose tolerance test

    Time frame: assessed at discharge (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.

Secondary outcomes

  1. Measure concentrations of serum cytokines

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

    Inflammatory response will be assessed by measuring the concentrations (in pg/ml)of a panel of serum cytokines (IL-1, IFN, TNF etc.) using the Bio-Plex 17-Plex Suspension assay.

  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 the episodes of Pneumonia

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

    Pneumonia is defined by new progressive and persistent infiltrate, consolidation or cavitations, inhalation injury based on chest X-ray. We will also follow the guidelines provided by the American Burn Association on the definition of Pneumonia in burn patients. Change in sputum (purulent or increased) will also be recorded.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2011
Registry last updated
Mar 28, 2022

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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