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

Study Overview
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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).

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

Conditions
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Rheumatic Disease of Heart Valve, Ischemic Reperfusion Injury

Intervention / Treatment
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* Device: Remote ischemic postconditioning


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Tourniquet<br> | Device: Remote ischemic postconditioning<br>* 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.<br>* Other names: Manual Tourniquet YZ-01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function |  | within the first 48h after cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of troponin I (cTnI) |  | within 48h after cardiac surgery | 
| Myocardial enzyme |  | within 48h after cardiac surgery | 
| Cystatin C |  | within 48h after cardiac surgery | 
| High-sensitivity c-reactive protein(HS-CRP) |  | within 48h after cardiac surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemia reperfusion injury, Cardiopulmonary bypass, Remote Ischemic Postconditioning, Other Functional Disturbances Following Cardiac Surgery