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

December 24, 2013 updated by: Jong Hwan Lee, Samsung Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
no intervention
Experimental: RIPC group
Those undergoing remote ischemic postconditioning
Other: 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.
Other Names:
  • remote ischemic postconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total bilirubin
Time Frame: before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
total bilirubin before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Function Test profiles
Time Frame: Before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
Serum BUN, creatinine concentration, estimated GFR and urine output before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
Before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
Liver Function Test Profiles
Time Frame: before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
AST, ALT, albumin, before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
incidence of Surgical Outcome
Time Frame: 1 week, 1 month after the end of surgery
incidence of acute rejection of transplanted Liver (Biopsy-confirmed or clinically symptomatic),incidence of Delayed graft function : clinically symptomatic, incidecne of Postoperative renal replacement therapy
1 week, 1 month after the end of surgery
Length of hospital stay (days)
Time Frame: 1 month, 2 month, 3 month after the end of surgery
total hospital stay, ICU stay, postoperative stay
1 month, 2 month, 3 month after the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

December 25, 2013

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-06-010-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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