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

Primary Purpose

Congenital Heart Disease

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Sponsored by
Aymen N Naguib
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with the following diagnosis:

    1. ASD
    2. VSD
    3. AVSD
    4. TOF
    5. 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:

    1. HLHS
    2. Aortic arch reconstruction
    3. Arterial switch
    4. TOF with pulmonary atresia

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine

Placebo

Arm Description

Dexmedetomidine in addition to 15 µg/kg of fentanyl

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

Outcomes

Primary Outcome Measures

Change in cytokine levels
Cytokine levels in plasma and MUF 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.
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.
Change in neurodevelopmental 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.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2015
Last Updated
February 27, 2023
Sponsor
Aymen N Naguib
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1. Study Identification

Unique Protocol Identification Number
NCT02492269
Brief Title
Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aymen N Naguib

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
Change in cytokine levels
Description
Cytokine levels in plasma and MUF 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.
Time Frame
From baseline to 24 hrs post-op
Title
Change in hormone levels
Description
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.
Time Frame
From baseline to 24 hrs post-op
Title
Change in neurodevelopmental scores
Description
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.
Time Frame
From baseline to 1 year post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

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

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