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CompletedNCT01920542Updated Nov 10, 2016

Dexmedetomidine on Pediatric Heart Operation

An interventional study of Dexmedetomidine and no dexmedetomidine in Acute Renal Injury, sponsored by Gachon University Gil Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2016-11-10.

Sponsored by Gachon University Gil Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
1 Year to 6 Years
Sex
All
01

Study summary

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

Read the 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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Conditions studied

  • Acute Renal Injury

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03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Gachon University Gil Medical Center is the lead sponsor of 88 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 1-6yr pediatric cardiac patients

Exclusion criteria

Exclusion Criteria:

  • previous renal dysfunction
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    no dexmedetomidine

    no administration of dexmedetomidine

    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

    Drug: Dexmedetomidine

Interventions

  • DrugDexmedetomidine

    administration of dexmedetomidine on dexemedetomidine group

    Also known as: administration of dexmedetomidine

  • Drugno dexmedetomidine

    no administration of dexmedetomidine on control group

    Also known as: no administration of dexmedetomidine

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What researchers measure

Primary outcomes

  1. 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

    Time frame: from anesthetic induction up to postoperative 2h

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Study locations

1 site
  • Gachon University Gil Medical Cneter
    Incheon, Korea, Republic of
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01920542
Lead sponsor
Gachon University Gil Medical Center
Responsible party
Youn Yi Jo (Assistant professor, Gachon University Gil Medical Center) — Principal investigator
First posted
Aug 12, 2013
Start date
Sep 2013
Primary completion
Jul 2016
Completion
Aug 2016
Last update
Nov 10, 2016

Study contacts

Kyung Cheon Lee, M.D., Ph.D
study director · Gachon University Gil Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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