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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT02720549

Collaborator

(none)

252

Enrollment

Location

Arms

13.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Valvular Heart Disease Patients	Procedure: remote ischemic postconditioning Procedure: valvular surgery with bypass	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

252 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Actual Study Start Date :

Mar 7, 2016

Actual Primary Completion Date :

Apr 14, 2017

Actual Study Completion Date :

Apr 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: post-ischemic conditioning group	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.
Placebo Comparator: valvular surgery with bypass group	Procedure: valvular surgery with bypass valvular surgery with bypass

Arm

Intervention/Treatment

Experimental: post-ischemic conditioning group

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.

Placebo Comparator: valvular surgery with bypass group

Procedure: valvular surgery with bypass

valvular surgery with bypass

Outcome Measures

Primary Outcome Measures

incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria [5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine and Anesthesia	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT02720549

Other Study ID Numbers:

4-2015-1198

First Posted:

Mar 28, 2016

Last Update Posted:

Jan 28, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Heart Diseases

Heart Valve Diseases

Study Results

No Results Posted as of Jan 28, 2019