Normoglycemia and Neurological Outcome

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

Follow up will occur at 3, 6 and 12 months.

The primary outcome measure will be neurological outcome at 12 months according to Karnofsky Performance Scale (KPS).

It had two arms (groups): Intensive IV Insulin (experimental) and Conventional Insulin Treatment (active comparator).

The registry classes the interventions as drug.

More on the Plan

Demographic data, social and medical histories, and clinical features at onset will be obtained via patient or family interview shortly after admission .

However, a twelve-hour period after ICU admission is necessary for initial diagnosis and assessment of the patient's status in order to identify the patient as a potential study subject and to get consent from the patient's legal representative.

Within twelve hours of ICU admission, qualifying patients will be randomized one of the two groups.

Randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes.

Who Took Part

The registry lists 56 actual participants took part.

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: Non-traumatic SAH, ICH, or TBI. Glasgow Coma Scale between 6 and 14.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: patients \<18 and \>80 years; GCS Motor score \<4 or an overall GCS score of 15; diabetic patients who suffer from dialysis-dependent diabetic nephropathy.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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 2007-01 with completion listed for 2014-12.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Karnovsky Performance Status Scale of Functional Impairment (time frame: 3 months).

It also tracked 1 secondary outcome, for example Blood Glucose Concentration.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 56 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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