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SPECS: Safe Pediatric Euglycemia in Cardiac Surgery (SPECS)

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michael Agus, Children's Hospital Boston Identifier:
First received: March 5, 2007
Last updated: August 19, 2016
Last verified: August 2016
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
Drug: Insulin
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
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 Boston Children’s Hospital:

Primary Outcome Measures:
  • Incidence of Nosocomial Infections in the Cardiac ICU [ Time Frame: Measured during participant's ICU stay, a median duration of 3 days. ]
    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 ]

Secondary Outcome Measures:
  • Duration of ICU Stay [ Time Frame: Measured at the end of participant's ICU stay ]
  • Duration of Hospital Stay [ Time Frame: Measured at the end of participant's hospital stay ]
  • Duration of Endotracheal Intubation [ Time Frame: Measured during participant's ICU stay ]
  • Mortality [ Time Frame: Measured during participant's hospital stay and at 30-day and 1-year follow-ups ]
  • Cardiac Function [ Time Frame: Measured during participant's ICU stay ]
  • Immune Function [ Time Frame: Measured during participant's ICU stay ]
  • Endocrine Function [ Time Frame: Measured during participant's ICU stay ]
  • Nutritional Status [ Time Frame: Measured during participant's ICU stay ]
  • Neurodevelopmental Evaluation [ Time Frame: 1 and 3 years of age ]

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.


Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its 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
Sponsors and Collaborators
Boston Children’s Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Michael Agus, MD Boston Children’s Hospital
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Agus, Assistant Professor, Harvard Medical School, Children's Hospital Boston Identifier: NCT00443599     History of Changes
Other Study ID Numbers: 512
5R01HL088448-05 ( US NIH Grant/Contract Award Number )
Study First Received: March 5, 2007
Results First Received: January 28, 2014
Last Updated: August 19, 2016

Keywords provided by Boston Children’s Hospital:
Congenital Heart Defects

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Glucose Metabolism Disorders
Metabolic Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 26, 2017