Phase 2
N=30
Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study
Congenital Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT02492269 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Change in Cytokine Levels — 4.38; 4.2; 3.98; 3.85 picograms per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexmedetomidine (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Aymen N Naguib
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cytokine Levels |
4.38; 4.2; 3.98; 3.85; 2.88; 2.72 | — |
| PRIMARY Change in Hormone Levels |
150.10; 139.48; 105.63; 94.2; 108.09; 199.34 | — |
| PRIMARY Change in Bayley Cognitive Composite Scores |
102.14; 95; 102.14; 88.33; 102.86; 96.82 | — |
| SECONDARY Change in Bayley Language Composite Scores |
98.14; 86.81; 91.14; 77.6; 92.5; 92.36 | — |
| SECONDARY Change in Bayley Motor Composite Scores |
95.14; 84.2; 92.07; 84.27; 92; 87.18 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02492269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.