Heart And Lung Failure - Pediatric INsulin Titration Trial

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): Tight Glycemic Control 1 (TGC-1) (active comparator) and Tight Glycemic Control 2 (TGC-2) (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 713 actual participants took part.

It was open to people of any sex aged from 2 Weeks up to 17 years.

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

Examples of who could join: Cardiovascular failure and/or respiratory failure:. Respiratory Failure: Acute mechanical ventilation via endotracheal tube or tracheostomy. Age \>= 2 weeks and corrected gestational age \>= 42 weeks. Age \< 18 years (has not yet had 18th birthday).

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: no longer has cardiovascular or respiratory failure (as defined in inclusion criterion 1), or is expected to be extubated in the next 24 hours; expected to remain in icu \< 24 hours; previously randomized in half-pint.

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

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

It started in 2012-04 with completion listed for 2016-09.

It ran at 35 sites in United States (33), Australia (1) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): ICU-Free Days (time frame: Study day 28).

It also tracked 20 secondary outcomes, for example Accumulation of Multiple Organ Dysfunction Syndrome (MODS), Ventilator-Free Days, Developmental Neurobehavioral Outcomes: VABS-II Composite, Participants With Device-Related or Non-Device Related Nosocomial Infection, Incidence of Catheter-Associated Urinary Tract Infection and Incidence of Ventilator-Associated Pneumonia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 713 people.

With 713 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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