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Effect of Remote Ischemic Preconditioning on Acute Kidney Injury in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass

NCT ID: NCT01023152

Last Updated: 2009-12-02

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

74 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to study the effect of remote ischemic preconditioning on acute kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary bypass.

Detailed Description

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Hypothesis : RIPC using tourniquet might be a simple technique with the benefit to provide renal protection without disturbing operating procedure and prolongation of total operating time.

Conditions

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Heart Valve Disease

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Study Groups

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Automated cuff-inflator

Group Type EXPERIMENTAL

Automated cuff-inflator

Intervention Type PROCEDURE

RIPC protocol consisted of three 10-min cycles of lower limb ischemia at an inflation pressure of 250 mmHg induced by an automated cuff-inflator placed on the upper leg with an intervening 10 min of reperfusion during which the cuff was deflated.

Interventions

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Automated cuff-inflator

RIPC protocol consisted of three 10-min cycles of lower limb ischemia at an inflation pressure of 250 mmHg induced by an automated cuff-inflator placed on the upper leg with an intervening 10 min of reperfusion during which the cuff was deflated.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing complex valve surgery.

Exclusion Criteria

* older than 80 years
* those with left main disease \>50%, or hepatic or pulmonary disease
* active infective endocarditis
* left ventricular ejection fraction \<30%
* myocardial infarction (MI) within 3 weeks
* pre-existing renal dysfunction (serum creatinine (Cr) level \>1.4 mg/dl), and those with peripheral vascular disease affecting the lower limbs.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Department of Anesthesiology and Pain Medicine, Severance Hospital

Other Identifiers

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4-2008-0423

Identifier Type: -

Identifier Source: org_study_id