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

Not Applicable

• Conditions: Rheumatic Disease of Heart Valve; Ischemic Reperfusion Injury
• Interventions: Device: Remote ischemic postconditioning

• Registration Number: NCT01476969
• Lead Sponsor: Central South University

Brief Summary

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

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).

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-11
• Last Update Posted: 2012-08-14
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Manual Tourniquet	Remote ischemic postconditioning	-

Primary Outcome Measures

Name	Time	Method
Renal function	within the first 48h after cardiac surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Central South University; 🇨🇳 Changsha, Hunan, China