Tight Glycemic Control With Intensive Insulin Therapy in PICU

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human).

The current prospective, randomized, controlled study will asses the impact of intensive insulin therapy on outcome of patients in a pediatric intensive care unit.

It had two arms (groups): A (active comparator) and B (experimental).

Conventional insulin therapy (using Actrapid IV).

Intensive insulin therapy (using actrapid IV).

The registry classes the interventions as drug.

Who Took Part

700 actual participants took part.

It was open to people of any sex aged from 1 Day up to 16 years.

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

Examples of who could join: Children admitted to the pediatric intensive care unit and anticipated to require intensive care for at least 24 hours.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: expected stay \< 24 hours; therapy restriction upon admission; no informed consent.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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 2004-10 with completion listed for 2008-02.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): duration of dependency on intensive care (days in ICU) (time frame: time in ICU).

It also tracked 4 secondary outcomes, for example Duration mechanical ventilation, Organ failure/need for organ support, mortality (safety endpoint) and long-term follow-up study : focus on neurocognitive development (ethical approval granted).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 700 people.

With 700 participants it is a large trial for this field.

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.