SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

What Was Tested

The trial (not phased) is built around Insulin (regular human).

It had two arms (groups): Insulin (experimental) and Usual Care (active comparator).

Insulin was infused according to the discretion of the treating clinical team.

The registry classes the interventions as drug and other.

More on the Plan

Participants will be randomly assigned to either a control group or the treatment group.

All participants will receive usual care while in the ICU and will undergo continuous glucose monitoring.

Thirty days and 1 year following surgery, study researchers will contact the participant's parent or doctor to collect information on health status and any new infections at the surgical site.

Who Took Part

The registry lists 989 actual participants took part.

It was open to people of any sex aged up to 36 months.

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

Examples of who could join: Recovering in the Cardiac ICU.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: enrolled in another interventional clinical trial with related study outcomes.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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 2006-11 with completion listed for 2012-06.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Incidence of Nosocomial Infections in the Cardiac ICU (time frame: Measured during participant's ICU stay, a median duration of 3 days).

It also tracked 13 secondary outcomes, for example Duration of ICU Stay, Duration of Endotracheal Intubation, Mortality at 30 Days, Cardiac Function, Immune Function and Endocrine Function.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 989 people.

With 989 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.