Glucose Control in Severely Burned Patients

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Burns

Treatments: Drug: Humulin R; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01307306

ins_met_jeschke

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Metformin

Experimental group

Treatment:

Drug: Metformin

Insulin

Experimental group

Treatment:

Drug: Humulin R

Control

No Intervention group