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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01637038
Collaborator
(none)
80
1
2
8
9.9

Study Details

Study Description

Brief Summary

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

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title:
The Effect of Remote Ischemic Postconditioning on Liver Graft and Renal Function in Patients Undergoing Living-related Liver Transplantation
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. total bilirubin [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

    Secondary Outcome Measures

    1. Renal Function Test profiles [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

    2. Liver Function Test Profiles [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

    3. incidence of Surgical Outcome [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

    4. Length of hospital stay (days) [1 month, 2 month, 3 month after the end of surgery]

      total hospital stay, ICU stay, postoperative stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jong Hwan Lee, Assistant Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01637038
    Other Study ID Numbers:
    • 2012-06-010-001
    First Posted:
    Jul 10, 2012
    Last Update Posted:
    Dec 25, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Jong Hwan Lee, Assistant Professor, Samsung Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 25, 2013