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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: November 2012

Detailed Description

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).

Interventions

  • Device: 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.

Arms, Groups and Cohorts

  • Experimental: Manual Tourniquet

Clinical Trial Outcome Measures

Primary Measures

  • Renal function
    • Time Frame: within the first 48h after cardiac surgery

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central South University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Luo Wanjun, Director – Central South University
  • Overall Official(s)
    • Luo Wanjun, M.D., Study Director, Central South University
  • Overall Contact(s)
    • Luo Wanjun, M.D., 86-731-89753503, luo3478@yahoo.cn

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