Liver Protection of RIPC in Pediatric Living Donor Liver Transplantation

Hepatic Ischemic and Reperfusion Injury Clinical Trial

— RIPC-PLDT  

Official title:

Remote Ischemic Preconditioning Protects Against Hepatic Ischemic and Reperfusion Injury in Pediatric Living Donor Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830841
• Other study ID #: Renji[2016]002k
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2019

Study information

• Verified date: April 2020
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Ischemic and Reperfusion Injury
• Ischemia
• Reperfusion Injury

Intervention

Device:
• remote 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.
• Sham RIPC
Only blood pressure cuff will be placed to the patient, but no inflation or deflation will be performed.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Görlich 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative maximum AST	Postoperative maximum aspartate transaminase (AST)	Postoperative 0-7 day
Primary	Postoperative maximum ALT	Postoperative maximum alanine transaminase (ALT)	Postoperative 0-7 day
Secondary	Occurrence of early graft dysfunction(EAD)	occurrence of early graft dysfunction	7 days after surgery
Secondary	Number of recipients with primary nonfunction	Number of recipients with primary nonfunction	7 days after surgery
Secondary	Number of recipients/donors with postoperative complications	Number of recipients/donors with postoperative complications	7 days after surgery
Secondary	The overall survival of recipients	1-year and 3-year overall survival of recipients after liver transplantation	1-year and 3-year overall survival of recipients