Liver Protection of RIPC in Pediatric Living Donor Liver Transplantation

NCT02830841 | Completed

• 1 other identifier: Renji[2016]002k
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Ischemic and Reperfusion Injury

Keywords

RIPC; hepatic ischemic and reperfusion injury; pediatric living donor liver transplantation

Outcome Measures

Primary Outcomes (2)

• Postoperative maximum AST

  Postoperative maximum aspartate transaminase (AST)

  Postoperative 0-7 day

• Postoperative maximum ALT

  Postoperative maximum alanine transaminase (ALT)

  Postoperative 0-7 day

Secondary Outcomes (4)

• Occurrence of early graft dysfunction(EAD)

  7 days after surgery

• Number of recipients with primary nonfunction

  7 days after surgery

• Number of recipients/donors with postoperative complications

  7 days after surgery

• The overall survival of recipients

  1-year and 3-year overall survival of recipients

Study Arms (4)

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.

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

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.

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.

Device: remote ischemic preconditioning(RIPC)

Interventions

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.

D-RIPC (donor RIPC group); DR-RIPC (donor and recipient RIPC group); R-RIPC (recipient RIPC group)

Sham RIPC DEVICE

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

S-RIPC (sham RIPC)

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (2)

• 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.

  PMID: 26024502 BACKGROUND

• 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. No abstract available.

  PMID: 26385818 BACKGROUND

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 13, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 6, 2020

Record last verified: 2020-04

Locations

CN (1)