Clinical trial NCT02830841: Liver Protection of RIPC in Pediatric Living Donor Liver Transplantation
Official title: Remote Ischemic Preconditioning Protects Against Hepatic Ischemic and Reperfusion Injury in Pediatric Living Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Ischemic and Reperfusion Injury
Keywords: RIPC
hepatic ischemic and reperfusion injury
pediatric living donor liver transplantation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 208
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Postoperative maximum AST
timeFrame: Postoperative 0-7 day
measure: Postoperative maximum ALT
timeFrame: Postoperative 0-7 day
Secondary outcomes:
measure: Occurrence of early graft dysfunction(EAD)
timeFrame: 7 days after surgery
measure: Number of recipients with primary nonfunction
timeFrame: 7 days after surgery
measure: Number of recipients/donors with postoperative complications
timeFrame: 7 days after surgery
measure: The overall survival of recipients
timeFrame: 1-year and 3-year overall survival of recipients
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References:
citation: Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Gorlich D, Kellum JA, Meersch M; RenalRIPC Investigators. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015 Jun 2;313(21):2133-41. doi: 10.1001/jama.2015.4189.
citation: Bulluck H, Candilio L, Hausenloy DJ. Remote Ischemic Preconditioning: Would You Give Your Right Arm to Protect Your Kidneys? Am J Kidney Dis. 2016 Jan;67(1):16-9. doi: 10.1053/j.ajkd.2015.08.018. Epub 2015 Sep 16. No abstract available.