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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

March 5, 2007
March 21, 2017
November 2006
June 2012   (Final data collection date for primary outcome measure)
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.
  • Incidence of Nosocomial Infections in the Cardiac ICU
  • Cardiac index (CI) 24 hours after cardiopulmonary bypass surgery
Complete list of historical versions of study NCT00443599 on ClinicalTrials.gov Archive Site
  • 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.
  • Duration of ICU Stay
  • Duration of Hospital Stay
  • Duration of Endotracheal Intubation
  • Mortality
  • Cardiac Function
  • Immune Function
  • Endocrine Function
  • Nutritional Status
Not Provided
Not Provided
 
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
Maintaining Normal Blood Sugar Levels in Children Undergoing Heart Surgery to Reduce the Risk of Infections and Improve Recovery (The SPECS Study)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
  • Heart Defects, Congenital
  • Hyperglycemia
  • 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
  • Other: Usual Care
    Participants receive standard Cardiac ICU care without tight blood glucose control.
  • Experimental: Insulin
    Insulin was infused to target a blood glucose concentration of 80-110 mg/dL
    Intervention: Drug: Insulin
  • Active Comparator: Usual Care
    Insulin was infused according to the discretion of the treating clinical team.
    Intervention: Other: Usual Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
989
January 2014
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 36 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00443599
512
5R01HL088448-05 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
Yes
Will share with investigators based upon specific requests
Michael Agus, Boston Children's Hospital
Boston Children’s Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Michael Agus, MD Boston Children’s Hospital
Boston Children’s Hospital
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP