Glucose Control in Severely Burned Patients

Burns Clinical Trial

Official title:

Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307306
• Other study ID #: ins_met_jeschke
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: March 2018

Study information

• Verified date: March 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Humulin R
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
Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.

Locations

Country	Name	City	State
Canada	Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 1-2 months post-admission, up to 6 months
Primary	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.	assessed at discharge (1-4 months post admission depending on the severity of injury)
Secondary	Measure concentrations of serum cytokines	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.	weekly until discharge (1-4 months post admission depending on severity of injury)
Secondary	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)
Secondary	Record the episodes of Pneumonia	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.	daily until discharge (1-4 months post admission depending on severity of injury)