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

Phase 2

Active, not recruiting

• Conditions: Congenital Heart Disease
• Interventions: Drug: Placebo; Drug: Dexmedetomidine

• Registration Number: NCT02492269
• Lead Sponsor: Aymen N Naguib

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-07-03
• Study First Posted: 2015-07-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with the following diagnosis:

  1. ASD
  2. VSD
  3. AVSD
  4. TOF
  5. Biventricular repair with left to right shunt.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine in addition to 15 µg/kg of fentanyl

Primary Outcome Measures

Name	Time	Method
Change in neurodevelopmental scores	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.
Change in cytokine levels	From baseline to 24 hrs post-op	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	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States