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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02720549
Other study ID # 4-2015-1198
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2016
Est. completion date April 14, 2017

Study information

Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 252
Est. completion date April 14, 2017
Est. primary completion date April 14, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Study Design


Intervention

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.
valvular surgery with bypass
valvular surgery with bypass

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine and Anesthesia Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria 5 days