Hepatic Ischemic and Reperfusion Injury
Conditions
Keywords
RIPC, hepatic ischemic and reperfusion injury, pediatric living donor liver transplantation
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.
Interventions
DEVICEremote ischemic preconditioning(RIPC)
After anesthesia induction, donors or recipients will be treated with automated blood pressure cuffs on their upper arms to receive RIPC by cuff inflation (to 15mmHg above systolic pressure) for 5 minutes and left inflated for 5 minutes. The cuff will then be deflated to 0 mm Hg and left uninflated for 5 minutes. This cycle will be performed 3 times in total.
DEVICESham RIPC
Only blood pressure cuff will be placed to the patient, but no inflation or deflation will be performed.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria were as follows: 1. American society of anesthesiologists score of I-III; 2. age of 3-72 months 3. elective living LT surgery. The
Exclusion criteria
were as follows: 1. peripheral vascular disease; 2. history of thromboembolism; 3. systemic or local infection before surgery; 4. autoimmune diseases; 5. severe congenital heart disease 6. history of LT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative maximum AST | Postoperative 0-7 day | Postoperative maximum aspartate transaminase (AST) |
| Postoperative maximum ALT | Postoperative 0-7 day | Postoperative maximum alanine transaminase (ALT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of early graft dysfunction(EAD) | 7 days after surgery | occurrence of early graft dysfunction |
| 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 |
| 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 |
Countries
China
Outcome results
None listed