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Dexmedetomidine on Pediatric Heart Operation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 8, 2013
First Posted Date  ICMJE August 12, 2013
Last Update Posted Date November 10, 2016
Study Start Date  ICMJE September 2013
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01920542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine on Pediatric Heart Operation
Official Title  ICMJE Renal Effects of Dexmedetomidine During Pediatric Cardiac Surgery: a Randomized Placebo-controlled Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Renal Injury
Intervention  ICMJE
  • Drug: Dexmedetomidine
    administration of dexmedetomidine on dexemedetomidine group
    Other Name: administration of dexmedetomidine
  • Drug: no dexmedetomidine
    no administration of dexmedetomidine on control group
    Other Name: no administration of dexmedetomidine
Study Arms  ICMJE
  • Experimental: no dexmedetomidine
    no administration of dexmedetomidine
    Intervention: Drug: no 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
    Intervention: Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1-6yr pediatric cardiac patients

Exclusion Criteria:

  • previous renal dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920542
Other Study ID Numbers  ICMJE GCIRB2013-163
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Youn Yi Jo, Gachon University Gil Medical Center
Study Sponsor  ICMJE Gachon University Gil Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kyung Cheon Lee, M.D., Ph.D Gachon University Gil Medical Center
PRS Account Gachon University Gil Medical Center
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP