The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery

Overview

Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing valvular heart surgery. The incidence of postoperative renal dysfunction was reported as high as 7~8% in heart surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury in previous animal studies and stoke patients. Therefore, the investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on postoperative renal dysfunction in subjects undergoing valvular heart surgery with bypass.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: April 14, 2017

Interventions

• Procedure: remote ischemic postconditioning
  • Remote ischemic postconditioning post group will take a remote ischemic postconditioning with tourniquet in their lower extremity under thigh. The conditioning is 5 minutes of inflation, and 5 minutes of deflation, repeated 3 cycles.
• Procedure: valvular surgery with bypass
  • valvular surgery with bypass

Arms, Groups and Cohorts

• Experimental: post-ischemic conditioning group
• Placebo Comparator: valvular surgery with bypass group

Clinical Trial Outcome Measures

Primary Measures

• incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria
  • Time Frame: 5 days

Participating in This Clinical Trial

Inclusion Criteria

• patients who are undergoing valvular heart surgery – Adult – age 19-80 Exclusion Criteria:

• peripheral vascular disease with circulation deterioration – Renal replacement therapy – preconditioning medication – Myocardiac infarction within 3 weeks – active infective endocarditis – high dosage steroid therapy – mental retardation – unlettered person

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Yonsei University
• Provider of Information About this Clinical Study
  • Sponsor