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SPECS: Safe Pediatric Euglycemia in Cardiac Surgery (SPECS)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michael Agus, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT00443599
First received: March 5, 2007
Last updated: March 21, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 Michael Agus, 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. These definitions are extensive and cannot be accurately condensed to fit within this space. Current CDC/NHSN criteria may be accessed through this URL: https://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf.


Secondary Outcome Measures:
  • Cardiac Index (CI) [ Time Frame: Day 2 (day after cardiopulmonary bypass surgery). ]
    Cardiac index is a measure of cardiac function, relating the cardiac output from the left ventricle in one minute to body surface area. It is calculated using the Fick principle, using oxygen consumption measured with a metabolic cart, hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation measured by co-oximetry.

  • Duration of ICU Stay [ Time Frame: The duration of cardiac ICU stay was evaluated from the date of postoperative cardiac ICU admission until the date of cardiac ICU discharge or date of death from any cause, whichever came first, assessed up to 30 days. ]
    Duration of ICU stay spans from post-operative cardiac ICU admission to cardiac ICU discharge.

  • Duration of Hospital Stay [ Time Frame: The duration of hospital stay was evaluated from the day of postoperative cardiac ICU admission until the day of hospital discharge or day of death from any cause, whichever came first, assessed up to 30 days. ]
    Duration of hospital stay spans from post-operative cardiac ICU admission to hospital discharge.

  • Duration of Endotracheal Intubation [ Time Frame: The duration of endotracheal intubation (mechanical ventilation) was evaluated from the day of postoperative cardiac ICU admission until the day of extubation or day of death from any cause, whichever came first, assessed up to 30 days. ]
    Duration of endotracheal intubation spans from endotracheal tube intubation/initiation of mechanical ventilation to endotracheal tube extubation.

  • Mortality at Hospital Discharge. [ Time Frame: Mortality at hospital discharge (In-hospital mortality) was evaluated on the day of hospital discharge or day of death from any cause, whichever came first (no upper limit). ]
    Mortality is assessed at hospital discharge and at 30 days.

  • Mortality at 30 Days. [ Time Frame: Measured at 30 days. ]
    Mortality is assessed at hospital discharge and at 30 days. If the participant is discharged from the hospital prior to 30 days, status is determined by a follow-up phone call to the family.

  • Cardiac Function [ Time Frame: The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days. ]
    Cardiac function is assessed by duration of vasoactive support.

  • Immune Function [ Time Frame: Post-operative day 7. ]
    Immune function is assessed by C-reactive protein (CRP) on post-operative day 7.

  • Endocrine Function [ Time Frame: Measured during participant's ICU stay on Day 7. ]
    Endocrine function is assessed by total triiodothyronine (T3) on post-operative day 7.

  • Nutritional Status [ Time Frame: The percentage of total caloric intake was evaluated from the day of postoperative cardiac ICU admission until the last day of the critical illness period, as defined by the presence of the arterial catheter, assessed up to 30 days. ]
    Nutritional status assessed by percentage of total caloric intake as enteral nutrition during critical illness period.

  • Neurodevelopmental Evaluation, Cognitive [ Time Frame: Measured at one year of age. ]

    Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.

    • Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.
    • Higher values indicate better neurodevelopmental outcomes.
    • These three composite scores cannot be combined and are presented as separate scores in the literature.

  • Neurodevelopmental Evaluation, Language [ Time Frame: Measured at one year of age. ]

    Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.

    • Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.
    • Higher values indicate better neurodevelopmental outcomes.
    • These three composite scores cannot be combined and are presented as separate scores in the literature.

  • Neurodevelopmental Evaluation, Motor [ Time Frame: Measured at one year of age. ]

    Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.

    • Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.
    • Higher values indicate better neurodevelopmental outcomes.
    • These three composite scores cannot be combined and are presented as separate scores in the literature.


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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Boston Children’s Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Michael Agus, MD Boston Children’s Hospital
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Agus, Assistant Professor, Harvard Medical School, Boston Children's Hospital
ClinicalTrials.gov 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: March 21, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Will share with investigators based upon specific requests

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

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

ClinicalTrials.gov processed this record on June 23, 2017