SPECS: Safe Pediatric Euglycemia in Cardiac Surgery (SPECS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Maintaining Normal Blood Sugar Levels in Children Undergoing Heart Surgery to Reduce the Risk of Infections and Improve Recovery (The SPECS Study)|
- Incidence of Nosocomial Infections in the Cardiac ICU [ Time Frame: Measured during participant's ICU stay, a median duration of 3 days. ] [ Designated as safety issue: No ]Nosocomial infections that are attributable to the subject's stay in the Cardiac ICU, according to Center for Disease Control-defined criteria.
- Cardiac Index (CI) [ Time Frame: Measured 24 hours after cardiopulmonary bypass surgery ] [ Designated as safety issue: No ]
- Duration of ICU Stay [ Time Frame: Measured at the end of participant's ICU stay ] [ Designated as safety issue: No ]
- Duration of Hospital Stay [ Time Frame: Measured at the end of participant's hospital stay ] [ Designated as safety issue: No ]
- Duration of Endotracheal Intubation [ Time Frame: Measured during participant's ICU stay ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: Measured during participant's hospital stay and at 30-day and 1-year follow-ups ] [ Designated as safety issue: No ]
- Cardiac Function [ Time Frame: Measured during participant's ICU stay ] [ Designated as safety issue: No ]
- Immune Function [ Time Frame: Measured during participant's ICU stay ] [ Designated as safety issue: No ]
- Endocrine Function [ Time Frame: Measured during participant's ICU stay ] [ Designated as safety issue: No ]
- Nutritional Status [ Time Frame: Measured during participant's ICU stay ] [ Designated as safety issue: No ]
- Neurodevelopmental Evaluation [ Time Frame: 1 and 3 years of age ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2006|
|Study Completion Date:||January 2014|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Insulin was infused to target a blood glucose concentration of 80-110 mg/dL
Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
Active Comparator: Usual Care
Insulin was infused according to the discretion of the treating clinical team.
Other: Usual Care
Participants receive standard Cardiac ICU care without tight blood glucose control.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443599
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|C.S. Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Michael Agus, MD||Boston Children’s Hospital|