search
Back to results

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

Primary Purpose

Valvular Heart Disease Patients

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remote ischemic postconditioning
valvular surgery with bypass
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Valvular Heart Disease Patients

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine and Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

post-ischemic conditioning group

valvular surgery with bypass group

Arm Description

Outcomes

Primary Outcome Measures

incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria

Secondary Outcome Measures

Full Information

First Posted
March 22, 2016
Last Updated
January 24, 2019
Sponsor
Yonsei University
search

1. Study Identification

Unique Protocol Identification Number
NCT02720549
Brief Title
The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2016 (Actual)
Primary Completion Date
April 14, 2017 (Actual)
Study Completion Date
April 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease Patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
post-ischemic conditioning group
Arm Type
Experimental
Arm Title
valvular surgery with bypass group
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
remote ischemic postconditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
valvular surgery with bypass
Intervention Description
valvular surgery with bypass
Primary Outcome Measure Information:
Title
incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine and Anesthesia
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30336847
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs