Dexmedetomidine on Pediatric Heart Operation

NCT ID: NCT01920542

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-08-31

Brief Summary

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we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

Detailed Description

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dexmedetomidine, a2-adrenoreceptor agonist has been used for sedation or hemodynamic stability for operative procedure. It had been already reported that dexmedetomidine reduce the impairment of renal functon after cardiac operation in adult. we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

Conditions

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Acute Renal Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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no dexmedetomidine

no administration of dexmedetomidine

Group Type EXPERIMENTAL

no dexmedetomidine

Intervention Type DRUG

no administration of dexmedetomidine on control group

dexmedetomidine

administration of 0.5ug/kg dexmedetomidine for 10 min and infusion of 0.5ug/kg/h of dexmedetomidine until weaning of cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

administration of dexmedetomidine on dexemedetomidine group

Interventions

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Dexmedetomidine

administration of dexmedetomidine on dexemedetomidine group

Intervention Type DRUG

no dexmedetomidine

no administration of dexmedetomidine on control group

Intervention Type DRUG

Other Intervention Names

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administration of dexmedetomidine no administration of dexmedetomidine

Eligibility Criteria

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Inclusion Criteria

* 1-6yr pediatric cardiac patients

Exclusion Criteria

* previous renal dysfunction
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Youn Yi Jo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung Cheon Lee, M.D., Ph.D

Role: STUDY_DIRECTOR

Gachon University Gil Medical Center

Locations

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Gachon University Gil Medical Cneter

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GCIRB2013-163

Identifier Type: -

Identifier Source: org_study_id