The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery
1 other identifier
interventional
252
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2016
CompletedFirst Submitted
Initial submission to the registry
March 22, 2016
CompletedFirst Posted
Study publicly available on registry
March 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2017
CompletedJanuary 28, 2019
January 1, 2019
1.1 years
March 22, 2016
January 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria
5 days
Study Arms (2)
post-ischemic conditioning group
EXPERIMENTALvalvular surgery with bypass group
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- patients who are undergoing valvular heart surgery
- Adult
- age 19-80
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine and Anesthesia
Seoul, 120-752, South Korea
Related Publications (1)
Song JW, Lee WK, Lee S, Shim JK, Kim HJ, Kwak YL. Remote ischaemic conditioning for prevention of acute kidney injury after valvular heart surgery: a randomised controlled trial. Br J Anaesth. 2018 Nov;121(5):1034-1040. doi: 10.1016/j.bja.2018.07.035. Epub 2018 Sep 18.
PMID: 30336847DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2016
First Posted
March 28, 2016
Study Start
March 7, 2016
Primary Completion
April 14, 2017
Study Completion
April 14, 2017
Last Updated
January 28, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share