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Completed

NCT Number: NCT02492269

Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study

The overall goal of this project is to determine the role of anesthetic management in children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress response as would be evident by the stress markers levels and the level of two cerebral injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative outcome and hopefully improve both the short and the long term neurodevelopmental outcome in these children. The project is prospective, randomized and blinded study. The first and second aim of the study should be conducted over 2 year period. Our long term aim will be concluded when these children reach the school age.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with the following diagnosis:
  • ASD
  • VSD
  • AVSD
  • TOF
  • Biventricular repair with left to right shunt.

Exclusion criteria

  • Patients with the diagnosis of AVSD and pulmonary hypertension
  • Patients less than 1 year and require any of the following repairs:
  • HLHS
  • Aortic arch reconstruction
  • Arterial switch
  • TOF with pulmonary atresia

Treatment and study plan

Dexmedetomidine

Drug

Other names: Precedex

Placebo

Drug

Other names: normal saline

Primary outcomes

  1. Change in Cytokine Levels

    Time frame: From baseline to 24 hrs post-op

    Cytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.

  2. Change in Hormone Levels

    Time frame: From baseline to 24 hrs post-op

    ACTH, cortisol, epinephrine, & norepinephrine will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.

  3. Change in Bayley Cognitive Composite Scores

    Time frame: From baseline to 1 year post-op

    Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.

    Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.

    Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.

Secondary outcomes

  1. Change in Bayley Language Composite Scores

    Time frame: From baseline to 1 year post-op

    Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.

    Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.

    Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.

  2. Change in Bayley Motor Composite Scores

    Time frame: From baseline to 1 year post-op

    Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress.

    Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.

    Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.

Sponsors and collaborators

Lead sponsor

Aymen N Naguib

Other

Registry information

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2015
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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