Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery
Primary Purpose
Congenital Heart Disease
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Congenital Heart Disease
Eligibility Criteria
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
Sites / Locations
- Seoul national university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine
Control
Arm Description
Outcomes
Primary Outcome Measures
Bayley scales of Infant development
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
neurodevelopment biomarker
plasma glial fibrillary acidic protein concentration
inflammation
level of IL-6
acute kidney injury
urinary NGAL
myocardial injury
level of Troponin i
anesthesia monitoring
Bispectral index, end tidal sevoflurane
fluid management
amount of transfusion, ROTEM® values
fluid management
blood loss
Full Information
NCT ID
NCT04484922
First Posted
July 21, 2020
Last Updated
February 1, 2022
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04484922
Brief Title
Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery
Official Title
The Effect of Dexmedetomidine on Neuroprotection in Pediatric Cardiac Surgery Patients: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
continuous infusion of dexmedetomidine during the surgery
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
continuous infusion of normal saline during the surgery
Primary Outcome Measure Information:
Title
Bayley scales of Infant development
Description
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)
Time Frame
1 year after the surgery
Secondary Outcome Measure Information:
Title
neurodevelopment biomarker
Description
plasma glial fibrillary acidic protein concentration
Time Frame
intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery
Title
inflammation
Description
level of IL-6
Time Frame
4 hours after end of surgery
Title
acute kidney injury
Description
urinary NGAL
Time Frame
2 hours after end of cardiopulmonary bypass
Title
myocardial injury
Description
level of Troponin i
Time Frame
intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery
Title
anesthesia monitoring
Description
Bispectral index, end tidal sevoflurane
Time Frame
intraoperative (from anesthetic induction to end of surgery)
Title
fluid management
Description
amount of transfusion, ROTEM® values
Time Frame
intraoperative (from anesthetic induction to end of surgery)
Title
fluid management
Description
blood loss
Time Frame
intraoperative (from anesthetic induction to end of surgery)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun-hee Kim
Phone
+82-01-9933-5014
Email
beloveun@gmail.com
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-hee Kim
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35395776
Citation
Ji SH, Kang P, Song IS, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. The effect of dexmedetomidine on neuroprotection in pediatric cardiac surgery patients: study protocol for a prospective randomized controlled trial. Trials. 2022 Apr 8;23(1):271. doi: 10.1186/s13063-022-06217-9.
Results Reference
derived
Learn more about this trial
Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery
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