ClinicalTrials.gov
ClinicalTrials.gov Menu

Liver Protection of RIPC in Pediatric Living Donor Liver Transplantation (RIPC-PLDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02830841
Recruitment Status : Unknown
Verified July 2016 by RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatic Ischemic and Reperfusion Injury Device: remote ischemic preconditioning(RIPC) Device: Sham RIPC Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning Protects Against Hepatic Ischemic and Reperfusion Injury in Pediatric Living Donor Liver Transplantation
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DR-RIPC (donor and recipient RIPC group)
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.
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 Comparator: S-RIPC (sham RIPC)
Patients had a deflated cuff placed on the right upper arm or right lower limb for 30 min
Device: Sham RIPC
Only blood pressure cuff will be placed to the patient, but no inflation or deflation will be performed.

Experimental: R-RIPC (recipient RIPC group)
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.
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.

Experimental: D-RIPC (donor RIPC group)
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.
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.




Primary Outcome Measures :
  1. Transplanted liver function(AST) [ Time Frame: 3 days after surgery ]
    Aspartate transaminase(AST) level on day 3 post liver transplantation

  2. Transplanted liver function(ALT) [ Time Frame: 3 days after surgery ]
    Alanine transaminase(ALT) level on day 3 post liver transplantation


Secondary Outcome Measures :
  1. Occurrence of early graft dysfunction(EGD) [ Time Frame: 7 days after surgery ]
    occurrence of early graft dysfunction

  2. ICU stay [ Time Frame: after surgery before discharge within 30 days ]
    days spend in ICU within 30 days

  3. 30 day mortality [ Time Frame: 30 days after surgery ]
    patient mortality during the first 30 days after surgery

  4. Renal function [ Time Frame: 7 days after surgery ]
    Serum creatinine(SCr) level

  5. Number of participants with post operative pulmonary complication as assess by PPC evaluation form [ Time Frame: 14 days after surgery ]
  6. number of participants with survived graft at 1 year after surgery [ Time Frame: 1 year after surgery ]
  7. Age 2 neurodevelopmental score [ Time Frame: patient at the age of 2 ]
  8. number of survived patients at 1 year after surgery [ Time Frame: 1 year after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients between the age of 3 month and 6 years
  • Scheduled for living donor liver transplantation

Exclusion Criteria:

  • Re-transplantation
  • Patients with localized or systemic infection
  • Patients cor-morbid with auto-immune disease
  • Peripheral vascular disease
  • Prior history of thrombo-embolic disease
  • Combined liver and kidney transplantation
  • Lack of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830841


Contacts
Contact: Peiying Li, MD,PhD 86-15800616866 peiying.li@qq.com
Contact: Liqun Yang, MD,PhD 862168383702 lqyang72721@163.com

Locations
China, Shanghai
Renji Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: Weifeng Yu, MD,PhD    862168383702    yuweifeng@renji.com   
Principal Investigator: Liqun Yang, MD,PhD         
Principal Investigator: Peiying Li, MD,PhD         
Sponsors and Collaborators
RenJi Hospital

Publications:
Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02830841     History of Changes
Other Study ID Numbers: Renji[2016]002k
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by RenJi Hospital:
RIPC
hepatic ischemic and reperfusion injury
pediatric living donor liver transplantation

Additional relevant MeSH terms:
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications