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Status unknownNCT01886079Updated Jun 25, 2013

The Effects of Dexmedetomidine on Postoperative Renal Function in Valvular Heart Surgery

A Phase 4 interventional study of dexmedetomidine and Saline in Acute Kidney Injury, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-06-25.

Sponsored by Yonsei University · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study summary

The purpose of study is to compare the incidence of acute kidney injury in patients receiving perioperative dexmedetomidine or placebo undergoing valvular heart surgery.

02

Conditions studied

  • Acute Kidney 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 planned enrollment of 200 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • adult patients over the age of 20 scheduled for valvular heart surgery

Exclusion criteria

Exclusion Criteria:

  • Left ventricular-ejection fraction \< 30%
  • Preexisting congestive heart failure
  • Severe coronary artery disease
  • Hemodynamically unstable arrhythmia
  • Cardiogenic shock during perioperative period
  • Ventricular assist device
  • Severe renal dysfunction (eGFR \< 15ml/min per 1.73m2)
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Dexmedetomidine group

    Drug: dexmedetomidine

  • Placebo comparator
    Saline group

    Drug: Saline

Interventions

  • Drugdexmedetomidine

    0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery

  • DrugSaline

    0.4 mcg/kg/h, IV

06

What researchers measure

Primary outcomes

  1. Comparison of postoperative renal function in patients with or without dexmedetomidine undergoing valvular heart surgery:

    BUN/Creatinine, cystatin C, eGFR, urine output Incidence of acute kidney injury (based on the AKIN criteria)

    Time frame: 24 hours after surgery.

07

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
    Seoul, 120-752, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01886079
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jun 25, 2013
Start date
May 2013
Primary completion
May 2015 (estimated)
Completion
May 2015 (estimated)
Last update
Jun 25, 2013

Study contacts

Jong Wook Song, MD
Contact
SJW72331@yuhs.ac
82-2-2228-2420
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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