Intensive Versus Nonintensive Insulin Therapy for Hyperglycemia After Traumatic Brain Injury

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

Hyperglycemia is a manifestation of physiological and metabolic disorders after traumatic brain injury.

It had four arms (groups): Strict control group (experimental), Moderate control group (experimental), Slight control group (experimental) and Non-intensive insulin therapy (active comparator).

The registry classes the interventions as drug.

More on the Plan

Hyperglycemia induced by traumatic brain injury is directly correlated with patient prognosis.

Hyperglycemia occurred after traumatic brain injury and was treated with intensive insulin therapy.

It is well known that hyperglycemia will appear after traumatic brain injury.

However, there are few clinical studies addressing continuous dynamic monitoring of blood glucose of traumatic brain injury patients and the relationship between changes in blood glucose and the degree of traumatic brain injury.

Who Took Part

144 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Severe closed traumatic brain injury diagnosed in the clinic;. Severe closed traumatic brain injury verified by CT examinations;. Patients who are in accordance with the indications of craniotomy for severe traumatic brain injury;. Glasgow coma score between 3 and 8;. At the age of 18 - 80 years old;.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: at the age of \< 18 years old or \> 80 years old;; glasgow coma score \> 8;; patients combined with multiple site damage;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2014-06 with completion listed for 2016-06.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Monitoring of target blood glucose (time frame: 4 weeks).

It also tracked 2 secondary outcomes, for example Mortality and Evaluation of activity of daily living.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 144 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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