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

May 4, 2020 updated by: RenJi Hospital

Remote Ischemic Preconditioning Protects Against Hepatic Ischemic and Reperfusion Injury 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative maximum AST
Time Frame: Postoperative 0-7 day
Postoperative maximum aspartate transaminase (AST)
Postoperative 0-7 day
Postoperative maximum ALT
Time Frame: Postoperative 0-7 day
Postoperative maximum alanine transaminase (ALT)
Postoperative 0-7 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of early graft dysfunction(EAD)
Time Frame: 7 days after surgery
occurrence of early graft dysfunction
7 days after surgery
Number of recipients with primary nonfunction
Time Frame: 7 days after surgery
Number of recipients with primary nonfunction
7 days after surgery
Number of recipients/donors with postoperative complications
Time Frame: 7 days after surgery
Number of recipients/donors with postoperative complications
7 days after surgery
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
1-year and 3-year overall survival of recipients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Renji[2016]002k

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