Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04484922
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 33.1
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Drug: Dexmedetomidine; Drug: Normal saline	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Dexmedetomidine on Neuroprotection in Pediatric Cardiac Surgery Patients: a Randomized Controlled Trial
• Actual Study Start Date: Aug 25, 2020
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine	Drug: Dexmedetomidine; continuous infusion of dexmedetomidine during the surgery
Placebo Comparator: Control	Drug: Normal saline; continuous infusion of normal saline during the surgery

Outcome Measures

Primary Outcome Measures

1. Bayley scales of Infant development [1 year after the surgery]

   Developmental outcomes at each assessment and within each domain (cognitive, language, and motor) were classified as "average" if they were within 1 SD of the mean or higher (scores .85), "at risk" if they were 1 to 2 SD below the mean (scores 70-84), and "delayed" if they were .2SD below the mean (,70). The trajectory of development over time in each domain (cognitive, language, and motor)

Secondary Outcome Measures

1. neurodevelopment biomarker [intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery]

   plasma glial fibrillary acidic protein concentration

2. inflammation [4 hours after end of surgery]

   level of IL-6

3. acute kidney injury [2 hours after end of cardiopulmonary bypass]

   urinary NGAL

4. myocardial injury [intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery]

   level of Troponin i

5. anesthesia monitoring [intraoperative (from anesthetic induction to end of surgery)]

   Bispectral index, end tidal sevoflurane

6. fluid management [intraoperative (from anesthetic induction to end of surgery)]

   amount of transfusion, ROTEM® values

7. fluid management [intraoperative (from anesthetic induction to end of surgery)]

   blood loss

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Year
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Neonates undergoing cardiac surgery

• Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair)

Exclusion Criteria:

• History of hypersensitivity of any drug

• Presence of hypotension or bradycardia considering age Bradycardia (heart rate < 80 beats/min) or hypotension (systolic blood pressure < 70mmHg for infants, < 60mmHg for neonates)

• Elevated liver enzyme levels (aspartate transaminase >100unit/L, alanine aminostrasferase > 50 unit/L)

• surgery with deep hypothermic circulatory arrest

• Presence of complex cardiac defect

• single ventricular physiology

• plan of additional operation within a year

• preoperative use of beta-agonists

• presence of history of any neurological disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul national university hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eun-hee Kim, Clinical assistant professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04484922
• Other Study ID Numbers: 2001-062-1095
• First Posted: Jul 24, 2020
• Last Update Posted: Feb 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital; Dexmedetomidine

Study Results

No Results Posted as of Feb 2, 2022