NCT04484922

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

July 21, 2020

Last Update Submit

February 1, 2022

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 year after the surgery

Secondary Outcomes (7)

  • neurodevelopment biomarker

    intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery

  • inflammation

    4 hours after end of surgery

  • acute kidney injury

    2 hours after end of cardiopulmonary bypass

  • myocardial injury

    intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery

  • anesthesia monitoring

    intraoperative (from anesthetic induction to end of surgery)

  • +2 more secondary outcomes

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL
Drug: Dexmedetomidine

Control

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

DexmedetomidineDRUG

continuous infusion of dexmedetomidine during the surgery

Dexmedetomidine
Normal salineDRUG

continuous infusion of normal saline during the surgery

Control

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35395776DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Eun-hee Kim

CONTACT

+82-01-9933-5014beloveun@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

August 25, 2020

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

February 2, 2022

Record last verified: 2022-02

Locations

KR(1)