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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2013

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • No Intervention: Control Group
    • no intervention
  • Experimental: RIPC group
    • Those undergoing remote ischemic postconditioning

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary 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
    • 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
    • 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
    • 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
    • total hospital stay, ICU stay, postoperative stay

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jong Hwan Lee, Assistant Professor – Samsung Medical Center
  • Overall Official(s)
    • Jong Hwan Lee, MD, PhD, Principal Investigator, Samsung Medical Center
    • Won Ho Kim, MD, Principal Investigator, Samsung Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.