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

NCT ID: NCT01886079

Last Updated: 2013-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dexmedetomidine group

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

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

Saline group

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

0.4 mcg/kg/h, IV

Interventions

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dexmedetomidine

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

Saline

0.4 mcg/kg/h, IV

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jong Wook Song, MD

Role: CONTACT

82-2-2228-2420

Other Identifiers

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4-2013-0194

Identifier Type: -

Identifier Source: org_study_id

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