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

Primary Purpose

Acute Kidney Injury

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine
Saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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)

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine group

Saline group

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
June 18, 2013
Last Updated
June 20, 2013
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01886079
Brief Title
The Effects of Dexmedetomidine on Postoperative Renal Function in Valvular Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Title
Saline group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
0.4 mcg/kg/h, IV
Primary Outcome Measure Information:
Title
Comparison of postoperative renal function in patients with or without dexmedetomidine undergoing valvular heart surgery:
Description
BUN/Creatinine, cystatin C, eGFR, urine output Incidence of acute kidney injury (based on the AKIN criteria)
Time Frame
24 hours after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients over the age of 20 scheduled for valvular heart surgery 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Wook Song, MD
Phone
82-2-2228-2420
Email
SJW72331@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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