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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: RIPC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>no intervention | |
| Experimental: RIPC group<br>Those undergoing remote ischemic postconditioning | Other: RIPC<br>* 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.<br>* Other names: remote ischemic postconditioning;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total bilirubin | 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 | 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 | 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 | 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) | total hospital stay, ICU stay, postoperative stay | 1 month, 2 month, 3 month after the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemia/reperfusion injury, remote ischemic postconditioning