The Effect of Remote Ischemic Postconditioning on Liver Graft and Renal Function in Patients Undergoing Living-related Liver Transplantation
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 6, 2012
CompletedFirst Posted
Study publicly available on registry
July 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedDecember 25, 2013
December 1, 2013
8 months
July 6, 2012
December 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Renal Function Test profiles
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
incidence of Surgical Outcome
1 week, 1 month after the end of surgery
Length of hospital stay (days)
1 month, 2 month, 3 month after the end of surgery
Study Arms (2)
Control Group
NO INTERVENTIONno intervention
RIPC group
EXPERIMENTALThose undergoing remote ischemic postconditioning
Interventions
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 Criteria
You may qualify if:
- Subjects undergoing living donor liver transplantation during the study period
- Subjects older than 20 yrs who can give written informed consent
You may not qualify if:
- Re-transplanted recipients
- Those with peripheral vascular diseases affecting the extremities
- Those with hepatic encephalopathy
- Those with cirrhotic cardiomyopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong Hwan Lee, MD, PhD
Samsung Medical Center
- PRINCIPAL INVESTIGATOR
Won Ho Kim, MD
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 6, 2012
First Posted
July 10, 2012
Study Start
June 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
December 25, 2013
Record last verified: 2013-12