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

Not Applicable

Completed

• Conditions: Valvular Heart Disease Patients
• Interventions: Procedure: remote ischemic postconditioning; Procedure: valvular surgery with bypass

• Registration Number: NCT02720549
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-07
• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-28
• Primary Completion: 2017-04-14
• Study Completion: 2017-04-14
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• patients who are undergoing valvular heart surgery
• Adult
• age 19-80

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
post-ischemic conditioning group	remote ischemic postconditioning	-
valvular surgery with bypass group	valvular surgery with bypass	-

Primary Outcome Measures

Name	Time	Method
incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria	5 days

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine and Anesthesia; 🇰🇷 Seoul, Korea, Republic of