Glucose Control in Severely Burned Patients

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human).

It had three arms (groups): Metformin (experimental), Insulin (experimental) and Control (no intervention).

The registry classes the interventions as drug.

Who Took Part

45 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Between 18 and 90 years of age. Admitted to the burn unit within 120 hours following burn. At least 1 surgical intervention necessary.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2011-03 with completion listed for 2018-03.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Perform oral glucose tolerance test (time frame: at 1-2 months post-admission, up to 6 months). Perform oral glucose tolerance test (time frame: assessed at discharge (1-4 months post admission depending on the severity of injury)).

It also tracked 3 secondary outcomes, for example Measure concentrations of serum cytokines, Record the episodes of sepsis and Record the episodes of Pneumonia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 45 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.