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Clinical Trials/NCT01476969
NCT01476969
Unknown
N/A

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

Central South University1 site in 1 country90 target enrollmentSeptember 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rheumatic Disease of Heart Valve
Sponsor
Central South University
Enrollment
90
Locations
1
Primary Endpoint
Renal function
Last Updated
13 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
November 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Central South University
Responsible Party
Principal Investigator
Principal Investigator

Luo Wanjun

Director

Central South University

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Renal function

Time Frame: within the first 48h after cardiac surgery

Secondary Outcomes

  • 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)

Study Sites (1)

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