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Dexmedetomidine on Pediatric Heart Operation

Primary Purpose

Acute Renal Injury

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
no dexmedetomidine
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Renal Injury

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1-6yr pediatric cardiac patients

Exclusion Criteria:

  • previous renal dysfunction

Sites / Locations

  • Gachon University Gil Medical Cneter

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

no dexmedetomidine

dexmedetomidine

Arm Description

no administration of dexmedetomidine

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

Outcomes

Primary Outcome Measures

renal function
at immediate after anesthetic induction (baseline), after weaning of cardiopulmonary bypass, 2h after end of operationCPB, sodium and creatinine in the urine and serum, N-acetyl-b-glucosaminidase (NAG)and albumin in only urine could be studied

Secondary Outcome Measures

Full Information

First Posted
August 8, 2013
Last Updated
November 8, 2016
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01920542
Brief Title
Dexmedetomidine on Pediatric Heart Operation
Official Title
Renal Effects of Dexmedetomidine During Pediatric Cardiac Surgery: a Randomized Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no dexmedetomidine
Arm Type
Experimental
Arm Description
no administration of dexmedetomidine
Arm Title
dexmedetomidine
Arm Type
Active Comparator
Arm Description
administration of 0.5ug/kg dexmedetomidine for 10 min and infusion of 0.5ug/kg/h of dexmedetomidine until weaning of cardiopulmonary bypass
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
administration of dexmedetomidine
Intervention Description
administration of dexmedetomidine on dexemedetomidine group
Intervention Type
Drug
Intervention Name(s)
no dexmedetomidine
Other Intervention Name(s)
no administration of dexmedetomidine
Intervention Description
no administration of dexmedetomidine on control group
Primary Outcome Measure Information:
Title
renal function
Description
at immediate after anesthetic induction (baseline), after weaning of cardiopulmonary bypass, 2h after end of operationCPB, sodium and creatinine in the urine and serum, N-acetyl-b-glucosaminidase (NAG)and albumin in only urine could be studied
Time Frame
from anesthetic induction up to postoperative 2h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1-6yr pediatric cardiac patients Exclusion Criteria: previous renal dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Cheon Lee, M.D., Ph.D
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Gachon University Gil Medical Cneter
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Dexmedetomidine on Pediatric Heart Operation

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