SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

Children undergoing heart surgery are under significant bodily stress, which can lead to
higher than normal or lower than normal blood glucose levels. A synthetic form of insulin, a
naturally occurring hormone in the body, can be injected into people to normalize blood
glucose levels. Insulin is most commonly used to treat people with diabetes, but it is also
used in hospitals to control blood glucose levels in patients. Previous studies of adult
intensive care unit (ICU) patients have shown that patients whose blood sugar levels are
maintained at normal levels with the use of insulin contract fewer infections and are
released more quickly from the ICU than patients who do not maintain normal blood glucose
levels. This study will use a continuous blood glucose monitoring system to detect changes in
blood glucose levels. Intravenous insulin infusions will be used to then safely maintain
normal blood glucose levels. The purpose of this study is to determine if maintaining normal
blood glucose levels during an ICU stay will help decrease the incidence of infections and
improve surgical recovery in young children following heart surgery.

This study will enroll children who are undergoing heart surgery that requires a
cardiopulmonary bypass procedure. 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. Participants in the treatment group will receive
intravenous insulin infusions to keep their blood glucose within the normal range. While in
the ICU, blood will be collected from all participants once a day for the first 3 days and
then once a week to monitor glucose levels, hormone levels, and measurements of nutrition and
immune function. On days 1 and 5 following surgery, participants who are on a ventilator will
have their breath measured to monitor heart function and energy use. 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. Children
who enroll in the study will be asked to participate in follow-up neurodevelopmental
evaluations at 1 and 3 years of age to assess longer term cognitive effects of tight glycemic
control in the ICU.

Inclusion Criteria:

- Undergoing heart surgery with cardiopulmonary bypass

- Recovering in the Cardiac ICU

Exclusion Criteria:

- Enrolled in another interventional clinical trial with related study outcomes