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

Yonsei University

Status: Completed

Conditions: Valvular Heart Disease Patients

Treatments: Procedure: remote ischemic postconditioning; Procedure: valvular surgery with bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT02720549

4-2015-1198

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups, including a placebo group

post-ischemic conditioning group

Experimental group

Treatment:

Procedure: remote ischemic postconditioning

valvular surgery with bypass group

Placebo Comparator group

Treatment:

Procedure: valvular surgery with bypass