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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jong Hwan Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01637038
First received: July 6, 2012
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Ischemia/Reperfusion Injury of Liver Graft
Ischemia/Reperfusion Injury of Kidney
Remote Ischemic Postconditioning
Other: RIPC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Effect of Remote Ischemic Postconditioning on Liver Graft and Renal Function in Patients Undergoing Living-related Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • total bilirubin [ Time Frame: before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery ] [ Designated as safety issue: No ]
    total bilirubin before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    AST, ALT, albumin, 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 ] [ Designated as safety issue: No ]
    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

  • Length of hospital stay (days) [ Time Frame: 1 month, 2 month, 3 month after the end of surgery ] [ Designated as safety issue: No ]
    total hospital stay, ICU stay, postoperative stay


Enrollment: 80
Study Start Date: June 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: remote ischemic postconditioning

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01637038

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Jong Hwan Lee, MD, PhD Samsung Medical Center
Principal Investigator: Won Ho Kim, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jong Hwan Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01637038     History of Changes
Other Study ID Numbers: 2012-06-010-001
Study First Received: July 6, 2012
Last Updated: December 24, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
ischemia/reperfusion injury
remote ischemic postconditioning

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications

ClinicalTrials.gov processed this record on September 18, 2014