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Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace

NCT ID: NCT01476969

Last Updated: 2012-08-14

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

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.

Detailed Description

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Methods: Patients meeting the requirement will be randomized into 2 groups: the treatment group consisted of three 5-minute cycles left lower limb ischemia, induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 5 minutes of reperfusion, during which time the cuff was deflate; the control group consisted of placing an uninflated cuff on the left lower limb for 30 minutes. The postconditioning protocol was applied after the aortic cross-clamping. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), Myocardial enzyme, Renal function, Cystatin c, and High-sensitivity c-reactive protein(HS-CRP).

Conditions

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Rheumatic Disease of Heart Valve Ischemic Reperfusion Injury

Keywords

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Ischemia reperfusion injury Cardiopulmonary bypass Remote Ischemic Postconditioning Other Functional Disturbances Following Cardiac Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Manual Tourniquet

Group Type EXPERIMENTAL

Remote ischemic postconditioning

Intervention Type DEVICE

the treatment group consisted of three 4-minute cycles left lower limb ischemia,induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 4 minutes of reperfusion ,during which time the cuff was deflate;the control group consisted of placing an uninflated cuff on the left lower limb for 24 minutes.The postconditioning protocol was applied after the aortic cross-clamping.

Interventions

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Remote ischemic postconditioning

the treatment group consisted of three 4-minute cycles left lower limb ischemia,induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 4 minutes of reperfusion ,during which time the cuff was deflate;the control group consisted of placing an uninflated cuff on the left lower limb for 24 minutes.The postconditioning protocol was applied after the aortic cross-clamping.

Intervention Type DEVICE

Other Intervention Names

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Manual Tourniquet YZ-01

Eligibility Criteria

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Inclusion Criteria

* rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement

Exclusion Criteria

* infective endocarditis congenital valve disease previous cardiac surgery complicated with rereplace valve
* Renal dysfunction
* diabetes
* coronary artery disease
* hypertension
* peripheral vascular disease affecting the lower limb free of arteriovenous fistula
* receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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Luo Wanjun

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luo Wanjun, M.D.

Role: STUDY_DIRECTOR

Central South University

Locations

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Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Luo Wanjun, M.D.

Role: CONTACT

Phone: 86-731-89753503

Email: [email protected]

Lv Hongwei, M.D.

Role: CONTACT

Phone: 86-13467616975

Email: [email protected]

Facility Contacts

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Luo Wanjun, M.D.

Role: primary

Lv Hongwei, M.D.

Role: backup

Other Identifiers

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CentralSouthU

Identifier Type: -

Identifier Source: org_study_id