SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

Boston Children's Hospital

Status: Completed

Conditions: Heart Defects, Congenital; Hyperglycemia

Treatments: Other: Usual Care; Drug: Insulin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00443599

512

5R01HL088448-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk of death. This study will examine the effectiveness of maintaining normal blood glucose levels at decreasing infections and improving recovery in young children undergoing heart surgery.

Full description

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.

Enrollment: 989 patients

Sex: All

Ages: Under 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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989 participants in 2 patient groups

Insulin

Experimental group

Description:

Insulin was infused to target a blood glucose concentration of 80-110 mg/dL

Treatment:

Drug: Insulin

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care