The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery

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

COMPLETED

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-07

Study Completion Date

2017-04-14

Brief Summary

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Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing valvular heart surgery. The incidence of postoperative renal dysfunction was reported as high as 7\~8% in heart surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury in previous animal studies and stoke patients. Therefore, the investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on postoperative renal dysfunction in subjects undergoing valvular heart surgery with bypass.

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Detailed Description

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Conditions

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Valvular Heart Disease Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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post-ischemic conditioning group

Group Type EXPERIMENTAL

remote ischemic postconditioning

Intervention Type PROCEDURE

Remote ischemic postconditioning post group will take a remote ischemic postconditioning with tourniquet in their lower extremity under thigh. The conditioning is 5 minutes of inflation, and 5 minutes of deflation, repeated 3 cycles.

valvular surgery with bypass group

Group Type PLACEBO_COMPARATOR

valvular surgery with bypass

Intervention Type PROCEDURE

valvular surgery with bypass

Interventions

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remote ischemic postconditioning

Remote ischemic postconditioning post group will take a remote ischemic postconditioning with tourniquet in their lower extremity under thigh. The conditioning is 5 minutes of inflation, and 5 minutes of deflation, repeated 3 cycles.

Intervention Type PROCEDURE

valvular surgery with bypass

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients who are undergoing valvular heart surgery
* Adult
* age 19-80

Exclusion Criteria

* peripheral vascular disease with circulation deterioration
* Renal replacement therapy
* preconditioning medication
* Myocardiac infarction within 3 weeks
* active infective endocarditis
* high dosage steroid therapy
* mental retardation
* unlettered person

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No