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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02492269
Other study ID # IRB13-00088
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 2014
Est. completion date December 2025

Study information

Verified date June 2024
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 1 Month to 12 Months
Eligibility 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

Study Design


Intervention

Drug:
Dexmedetomidine

Placebo


Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Aymen N Naguib

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From baseline to 24 hrs post-op
Primary 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
Primary 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. From baseline to 1 year post-op
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