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The Effect of Remote Ischemic Postconditioning on Liver Graft and Renal Function in Patients Undergoing Living-related Liver Transplantation

NCT ID: NCT01637038

Last Updated: 2013-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-02-28

Brief Summary

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The investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on liver graft function and postoperative renal function in subjects undergoing living-donor liver transplantation.

Detailed Description

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Ischemic reperfusion injury of liver graft and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing liver transplantation. The incidence of postoperative renal dysfunction was reported as high as 12 \~ 64% and is thought to be caused by ischemia/reperfusion injury. Ischemic pre- or postconditioning was reported to be effective for preventing ischemia/reperfusion injury during liver transplantation. Remote ischemic pre- or postconditioning was also reported to be protective for ischemia/reperfusion injury in major organs in previous animal studies. Therefore, we are trying to evaluate the clinical effect of remote ischemic postconditioning on liver graft function and postoperative renal function in subjects undergoing living-donor liver transplantation.

Conditions

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Ischemia/Reperfusion Injury of Liver Graft Ischemia/Reperfusion Injury of Kidney Remote Ischemic Postconditioning

Keywords

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ischemia/reperfusion injury remote ischemic postconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Group

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

RIPC group

Those undergoing remote ischemic postconditioning

Group Type EXPERIMENTAL

RIPC

Intervention Type OTHER

Those undergoing remote ischemic postconditioning. Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the unilateral upper limb and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.

Interventions

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RIPC

Those undergoing remote ischemic postconditioning. Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the unilateral upper limb and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.

Intervention Type OTHER

Other Intervention Names

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remote ischemic postconditioning

Eligibility Criteria

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Inclusion Criteria

* Subjects undergoing living donor liver transplantation during the study period
* Subjects older than 20 yrs who can give written informed consent

Exclusion Criteria

* Re-transplanted recipients
* Those with peripheral vascular diseases affecting the extremities
* Those with hepatic encephalopathy
* Those with cirrhotic cardiomyopathy
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong Hwan Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Hwan Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Won Ho Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2012-06-010-001

Identifier Type: -

Identifier Source: org_study_id