Hepatic Ischemic and Reperfusion InjuryRIPC-PLDTNCT02830841
Liver Protection of RIPC in Pediatric Living Donor Liver Transplantation
A study testing remote ischemic preconditioning(RIPC) in people with Hepatic Ischemic and Reperfusion Injury, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 months to 6 years
- Conditions the study is for
- Hepatic Ischemic and Reperfusion Injury
- What is being tested?
- remote ischemic preconditioning(RIPC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 6 years
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatic Ischemic and Reperfusion Injury
- Being tested
- remote ischemic preconditioning(RIPC), Sham RIPC
- Keywords
- RIPC, hepatic ischemic and reperfusion injury, pediatric living donor liver transplantation
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 RIPCDevice
Only blood pressure cuff will be placed to the patient, but no inflation or deflation will be performed.
| Study group | Role | What they receive |
|---|---|---|
| DR-RIPC (donor and recipient RIPC group) | Experimental | 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. Receives: Device: remote ischemic preconditioning(RIPC) |
| S-RIPC (sham RIPC) | Sham comparator | Patients had a deflated cuff placed on the right upper arm or right lower limb for 30 min Receives: Device: Sham RIPC |
| R-RIPC (recipient RIPC group) | Experimental | 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. Receives: Device: remote ischemic preconditioning(RIPC) |
| D-RIPC (donor RIPC group) | Experimental | 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. Receives: Device: remote ischemic preconditioning(RIPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative maximum AST
Postoperative maximum aspartate transaminase (AST)
Measured: Postoperative 0-7 day
Postoperative maximum ALT
Postoperative maximum alanine transaminase (ALT)
Measured: Postoperative 0-7 day
Secondary outcomes (4)
Occurrence of early graft dysfunction(EAD)
occurrence of early graft dysfunction
Measured: 7 days after surgery
Number of recipients with primary nonfunction
Number of recipients with primary nonfunction
Measured: 7 days after surgery
Number of recipients/donors with postoperative complications
Number of recipients/donors with postoperative complications
Measured: 7 days after surgery
The overall survival of recipients
1-year and 3-year overall survival of recipients after liver transplantation
Measured: 1-year and 3-year overall survival of recipients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatic Ischemic and Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830841
- Sponsor's protocol ID
- Renji[2016]002k
- Acronym
- RIPC-PLDT
- Status last verified
- Apr 2020
- First submitted
- 27 Jun 2016
- Last updated
- 6 May 2020
- Results posted
- No
Publications
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.
PubMed 26024502Bulluck 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.
PubMed 26385818
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning Protects Against Hepatic Ischemic and Reperfusion Injury in Pediatric Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT02830841
- Acronym / sponsor ID
- RIPC-PLDT / Renji[2016]002k
- Conditions
- Hepatic Ischemic and Reperfusion Injury
- Keywords
- RIPC, hepatic ischemic and reperfusion injury, pediatric living donor liver transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DR-RIPC (donor and recipient RIPC group) | Experimental | Device: remote ischemic preconditioning(RIPC)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. |
| S-RIPC (sham RIPC) | Sham comparator | Device: Sham RIPCPatients had a deflated cuff placed on the right upper arm or right lower limb for 30 min |
| R-RIPC (recipient RIPC group) | Experimental | Device: remote ischemic preconditioning(RIPC)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. |
| D-RIPC (donor RIPC group) | Experimental | Device: remote ischemic preconditioning(RIPC)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. |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | D-RIPC (donor RIPC group), DR-RIPC (donor and recipient RIPC group), R-RIPC (recipient RIPC group) |
| Sham RIPCOnly blood pressure cuff will be placed to the patient, but no inflation or deflation will be performed. | Device | S-RIPC (sham RIPC) |
Primary outcome
Postoperative maximum AST
Time frame: Postoperative 0-7 day
Postoperative maximum aspartate transaminase (AST)
Postoperative maximum ALT
Time frame: Postoperative 0-7 day
Postoperative maximum alanine transaminase (ALT)
4 secondary outcomes
Occurrence of early graft dysfunction(EAD)
Time frame: 7 days after surgery
Number of recipients with primary nonfunction
Time frame: 7 days after surgery
Number of recipients/donors with postoperative complications
Time frame: 7 days after surgery
The overall survival of recipients
Time frame: 1-year and 3-year overall survival of recipients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Background: PubMed 26024502Zarbock 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.
- Background: PubMed 26385818Bulluck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic preconditioning(RIPC) in people with Hepatic Ischemic and Reperfusion Injury, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative maximum AST (time frame: Postoperative 0-7 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830841, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.