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Completed

NCT Number: NCT02830841

Liver Protection of RIPC in Pediatric Living Donor Liver Transplantation

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.

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Key information

Age range

3 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria were as follows:

  • American society of anesthesiologists score of I-III;
  • age of 3-72 months
  • elective living LT surgery.

The exclusion criteria were as follows:

  • peripheral vascular disease;
  • history of thromboembolism;
  • systemic or local infection before surgery;
  • autoimmune diseases;
  • severe congenital heart disease
  • history of LT.

Treatment and study plan

remote ischemic preconditioning(RIPC)

Device

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

Device

Only blood pressure cuff will be placed to the patient, but no inflation or deflation will be performed.

Primary outcomes

  1. Postoperative maximum AST

    Time frame: Postoperative 0-7 day

    Postoperative maximum aspartate transaminase (AST)

  2. Postoperative maximum ALT

    Time frame: Postoperative 0-7 day

    Postoperative maximum alanine transaminase (ALT)

Secondary outcomes

  1. Occurrence of early graft dysfunction(EAD)

    Time frame: 7 days after surgery

    occurrence of early graft dysfunction

  2. Number of recipients with primary nonfunction

    Time frame: 7 days after surgery

    Number of recipients with primary nonfunction

  3. Number of recipients/donors with postoperative complications

    Time frame: 7 days after surgery

    Number of recipients/donors with postoperative complications

  4. The overall survival of recipients

    Time frame: 1-year and 3-year overall survival of recipients

    1-year and 3-year overall survival of recipients after liver transplantation

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Acronym: RIPC-PLDT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 13, 2016
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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