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

Not Applicable

Completed

• Conditions: Ischemia/Reperfusion Injury of Liver Graft; Ischemia/Reperfusion Injury of Kidney; Remote Ischemic Postconditioning
• Interventions: Other: RIPC

• Registration Number: NCT01637038
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-10
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-24
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Subjects undergoing living donor liver transplantation during the study period
• Subjects older than 20 yrs who can give written informed consent

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Exclusion Criteria

• Re-transplanted recipients
• Those with peripheral vascular diseases affecting the extremities
• Those with hepatic encephalopathy
• Those with cirrhotic cardiomyopathy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC group	RIPC	Those undergoing remote ischemic postconditioning

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
Length of hospital stay (days)	1 month, 2 month, 3 month after the end of surgery	total hospital stay, ICU stay, postoperative stay

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of