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

NCT02492269 | Completed Phase 2 Results

• 1 other identifier: IRB13-00088
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (3)

• Change in Cytokine Levels

  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.

  From baseline to 24 hrs post-op

• Change in Hormone Levels

  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.

  From baseline to 24 hrs post-op

• Change in Bayley Cognitive Composite Scores

  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.

  From baseline to 1 year post-op

Secondary Outcomes (2)

• Change in Bayley Language Composite Scores

  From baseline to 1 year post-op

• Change in Bayley Motor Composite Scores

  From baseline to 1 year post-op

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine in addition to 15 µg/kg of fentanyl

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

Normal saline as a placebo in addition to 15 µg/kg of fentanyl

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Also known as: Precedex

Dexmedetomidine

Placebo DRUG

Also known as: normal saline

Placebo

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aymen N Naguib: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Aymen Naguib
• Organization: Nationwide Children's Hosp.

Aymen.Naguib@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Pediatric Cardiothoracic Anesthesia

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 8, 2015
• Study Start: May 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-07

Locations

US (1)