Liver Protection of RIPC in Pediatric Living Donor Liver Transplantation
- Conditions
- Hepatic Ischemic and Reperfusion Injury
- Interventions
- Device: remote ischemic preconditioning(RIPC)Device: Sham RIPC
- Registration Number
- NCT02830841
- Lead Sponsor
- RenJi Hospital
- Brief Summary
Remote ischemic preconditioning(RIPC) is emerging as an promising therapeutic paradigm to combat the detrimental impact of ischemic and reperfusion injury. In liver transplantation, ischemic and reperfusion injury severely impacts the post-surgery liver function and patient outcome. This prospective, double blind, randomized clinical trial is aimed to test the protective effect of RIPC against hepatic ischemic and reperfusion injury in pediatric liver transplantation.
- Detailed Description
Pediatric liver transplantation remains the major therapeutic strategy for pediatric biliary atresia patients. With almost 60 years of improvements and refinements in surgical techniques and perioperative management standards, liver transplantation is gaining popularity and gradually turns out to be the only curative treatment option for patients with irrevocable liver failure, such as childhood acute or chronic liver failure, inherited liver diseases and also biliary atresia. In liver transplantation, hepatic ischemic and reperfusion injury (HIRI) remains to be a critical clinical issue. Importantly, it is well known that the severity of HIRI may have fundamental impact on the transplanted organ function and long term graft survival. Furthermore, pediatric patients are more venerable and less tolerated to receive an ischemic donor liver due to their small body weight.Although detrimental impact of HIPI on graft function has long been recognized, little progress has been made to attenuate the severity of the HIPI compared to cardiac ischemic and reperfusion (IR) injury. In experimental animal models, remote ischemic preconditioning has been consistently shown to have beneficial effects. However, this protective paradigm has yet not been tested in liver transplantation patients in clinical scenario. Considering the growing number of pediatric patients undergoing liver transplantation and their possibly underdeveloped organ function, the investigators sought to determine whether remote ischemic preconditioning could ameliorate HIPI and improve long term graft/patient survival in pediatric liver transplantation patients using this double-blind randomized clinical trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DR-RIPC (donor and recipient RIPC group) remote ischemic preconditioning(RIPC) Both donors and recipients receive remote ischemic preconditioning, with three 5-min cycles of remote limb ischemia, which was induced by an automated cuff-inflator placed on the right upper arm(donor) or right lower limb(recipient) and inflated to 15 mmHg above systolic pressure, with an intervening 5 min of reperfusion during which the cuff was deflated. R-RIPC (recipient RIPC group) remote ischemic preconditioning(RIPC) Recipients receive remote ischemic preconditioning, with three 5-min cycles of remote limb ischemia, which was induced by an automated cuff-inflator placed on the right lower limb and inflated to 15 mmHg above systolic pressure, with an intervening 5 min of reperfusion during which the cuff was deflated. S-RIPC (sham RIPC) Sham RIPC Patients had a deflated cuff placed on the right upper arm or right lower limb for 30 min D-RIPC (donor RIPC group) remote ischemic preconditioning(RIPC) Donors receive remote ischemic preconditioning, with three 5-min cycles of remote limb ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 15 mmHg above systolic pressure, with an intervening 5 min of reperfusion during which the cuff was deflated.
- Primary Outcome Measures
Name Time Method Postoperative maximum ALT Postoperative 0-7 day Postoperative maximum alanine transaminase (ALT)
Postoperative maximum AST Postoperative 0-7 day Postoperative maximum aspartate transaminase (AST)
- Secondary Outcome Measures
Name Time Method Occurrence of early graft dysfunction(EAD) 7 days after surgery occurrence of early graft dysfunction
The overall survival of recipients 1-year and 3-year overall survival of recipients 1-year and 3-year overall survival of recipients after liver transplantation
Number of recipients with primary nonfunction 7 days after surgery Number of recipients with primary nonfunction
Number of recipients/donors with postoperative complications 7 days after surgery Number of recipients/donors with postoperative complications
Trial Locations
- Locations (1)
Renji Hospital
🇨🇳Shanghai, Shanghai, China