SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Agus, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00443599
First received: March 5, 2007
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Heart Defects, Congenital
Hyperglycemia
Drug: Insulin
Other: Usual Care

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Incidence of Nosocomial Infections in the Cardiac ICU [ Time Frame: Measured during participant's ICU stay ] [ Designated as safety issue: No ]
  • Cardiac Index (CI) [ Time Frame: Measured 24 hours after cardiopulmonary bypass surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 989
Study Start Date: November 2006
Study Completion Date: January 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin
Insulin was infused to target a blood glucose concentration of 80-110 mg/dL
Drug: Insulin
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.
Other Names:
  • Human regular insulin
  • Humulin R
  • Novolin R
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443599

Locations
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
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Michael Agus, MD Children's Hospital Boston
  More Information

Publications:

Responsible Party: Michael Agus, Assistant Professor, Harvard Medical School, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00443599     History of Changes
Other Study ID Numbers: 512, 5R01HL088448-05
Study First Received: March 5, 2007
Results First Received: January 28, 2014
Last Updated: March 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Boston:
Congenital Heart Defects
Insulin
Euglycemia
Normoglycemia

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Hyperglycemia
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014