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Dexmedetomidine on Pediatric Heart Operation

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ClinicalTrials.gov Identifier: NCT01920542
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):
Youn Yi Jo, Gachon University Gil Medical Center

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

Condition or disease Intervention/treatment Phase
Acute Renal Injury Drug: Dexmedetomidine Drug: no dexmedetomidine Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Renal Effects of Dexmedetomidine During Pediatric Cardiac Surgery: a Randomized Placebo-controlled Study
Study Start Date : September 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

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Arm Intervention/treatment
Experimental: no dexmedetomidine
no administration of dexmedetomidine
Drug: no dexmedetomidine
no administration of dexmedetomidine on control group
Other Name: no administration of dexmedetomidine

Active Comparator: dexmedetomidine
administration of 0.5ug/kg dexmedetomidine for 10 min and infusion of 0.5ug/kg/h of dexmedetomidine until weaning of cardiopulmonary bypass
Drug: Dexmedetomidine
administration of dexmedetomidine on dexemedetomidine group
Other Name: administration of dexmedetomidine




Primary Outcome Measures :
  1. renal function [ Time Frame: from anesthetic induction up to postoperative 2h ]
    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



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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1-6yr pediatric cardiac patients

Exclusion Criteria:

  • previous renal dysfunction

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920542


Locations
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Korea, Republic of
Gachon University Gil Medical Cneter
Incheon, Korea, Republic of
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
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Study Director: Kyung Cheon Lee, M.D., Ph.D Gachon University Gil Medical Center

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Responsible Party: Youn Yi Jo, Assistant professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01920542     History of Changes
Other Study ID Numbers: GCIRB2013-163
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action