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

Samsung Medical Center80 enrolled

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.

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

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

RIPCOTHER

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

total bilirubin

total bilirubin before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

Time frame: before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

Secondary Outcomes

Renal Function Test profiles

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

Time frame: Before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

Liver Function Test Profiles

AST, ALT, albumin, before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

Time frame: before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery

incidence of Surgical Outcome

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

Time frame: 1 week, 1 month after the end of surgery

Length of hospital stay (days)

total hospital stay, ICU stay, postoperative stay

Time frame: 1 month, 2 month, 3 month after the end of surgery

Data from ClinicalTrials.gov

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