SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

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.

Time frame: Measured during participant's ICU stay, a median duration of 3 days.

Cardiac function is assessed by duration of vasoactive support.

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 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.

Time frame: Day 2 (day after cardiopulmonary bypass surgery).

Population: This outcome (using indirect calorimetry) was not available at the Michigan site, and not captured in Boston participants A) who had been extubated or were receiving only pressure support ventilation, B) without a properly placed catheter allowing for a true mixed venous sample or C) for whom equipment malfunction precluded an accurate measurement.

Duration of endotracheal intubation spans from endotracheal tube intubation/initiation of mechanical ventilation to endotracheal tube extubation.

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 hospital stay spans from post-operative cardiac ICU admission to hospital discharge.

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 ICU stay spans from post-operative cardiac ICU admission to cardiac ICU discharge.

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.

Endocrine function is assessed by total triiodothyronine (T3) on post-operative day 7.

Time frame: Measured during participant's ICU stay on Day 7.

Population: Thyroid hormones were assayed only if the participant remained in the cardiac ICU and there was central venous or arterial access for blood sampling.

Immune function is assessed by C-reactive protein (CRP) on post-operative day 7.

Time frame: Post-operative day 7.

Population: Participants analyzed include those with adequate access for blood sampling, C-reactive protein (CRP) drawn on post-operative day 7 and successful processing and preparation of samples,

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.

Time frame: Measured at 30 days.

Population: This outcome was not measured for participants lost to follow-up at 30 days post cardiac surgery.

Mortality is assessed at hospital discharge and at 30 days.

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).

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.

Time frame: Measured at one year of age.

Population: Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing completed at greater than 18 months post eligibility.

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.

Time frame: Measured at one year of age.

Population: Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing was completed at greater than 18 months post eligibility.

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.

Time frame: Measured at one year of age.

Population: Participants were not eligible if: born before 3/1/2008 (1 year before start of testing); age greater than one year at time of surgery; died; lived abroad; parent/guardian declined; severe disability precluded testing; did not show for testing; testing completed at greater than 18 months post eligibility.

Nutritional status assessed by percentage of total caloric intake as enteral nutrition during critical illness period.

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.

Population: Nutritional intake was tracked during the period of critical illness, as defined by the presence of an arterial catheter.