Clinical trial NCT01637038: The Effect of Remote Ischemic Postconditioning on Liver Graft and Renal Function in Patients Undergoing Living-related Liver Transplantation
Official title: The Effect of Remote Ischemic Postconditioning on Liver Graft and Renal Function in Patients Undergoing Living-related Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemia/Reperfusion Injury of Liver Graft
Ischemia/Reperfusion Injury of Kidney
Remote Ischemic Postconditioning
Keywords: ischemia/reperfusion injury
remote ischemic postconditioning
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: total bilirubin
timeFrame: before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
Secondary outcomes:
measure: Renal Function Test profiles
timeFrame: Before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
measure: Liver Function Test Profiles
timeFrame: before surgery and at 6, 12, 24, 36, 48, 60, 72, 84, 96 hours after the end of surgery
measure: incidence of Surgical Outcome
timeFrame: 1 week, 1 month after the end of surgery
measure: Length of hospital stay (days)
timeFrame: 1 month, 2 month, 3 month after the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jong Hwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Won Ho Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: