Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study

NCT02635347 | Completed Results

• 1 other identifier: Pro20150002276
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver Transplantation (OLT). Remote ischemic conditioning will consist of 3 cycles of 5 minutes of lower limb ischemia induced via a mid-thigh pneumatic tourniquet, followed by 5 minutes of reperfusion. Interventions will take place after anesthesia induction but before surgery, at the completion of the procedure, and on the mornings of post-operative days 1-4.

Conditions

Liver Failure; Carcinoma, Hepatocellular

Keywords

Remote ischemic preconditioning; Remote ischemic perconditioning; Remote ischemic postconditioning; Remote ischemic conditioning; Orthotopic liver transplant; Brain Death Organ Donor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Completing Entire Intervention Protocol

  Proportion of enrolled liver recipients that complete all 6 remote ischemic conditioning (RIC) interventions.

  Pre-op - Post-op day 4

Secondary Outcomes (13)

• Intervention-related Pain Score

  Post-op days 1-4

• Withdrawal of Consent Due to Pain

  Pre-op - Post-op day 7

• Percentage of Participants Who Developed Early Allograft Dysfunction (EAD)

  Post-op days 0-7

• Percentage of Participants Who Developed Prolonged Respiratory Insufficiency (PRI)

  Post-op days 0-7

• Percentage of Participants Who Developed Acute Kidney Injury (AKI) Stages 2 or 3

  Post-op days 0-7

Study Arms (1)

Remote Ischemic Conditioning (RIC) group

EXPERIMENTAL

Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC

Procedure: Remote Ischemic Conditioning (RIC); Device: Pneumatic tourniquet

Interventions

Remote Ischemic Conditioning (RIC) PROCEDURE

Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh.

Remote Ischemic Conditioning (RIC) group

Pneumatic tourniquet DEVICE

Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions.

Remote Ischemic Conditioning (RIC) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\> 18 years of age) with acute and chronic liver failure requiring liver transplants or patients undergoing transplantation for hepatocellular carcinoma.
• Both sexes
• Written consent to participate in the study

You may not qualify if:

• \< 18 years of age
• Recipients of split livers
• Retransplantation
• Recipients of livers combined with other organs
• Recipients of livers from cardiac death donors
• Lower extremity amputees
• History of peripheral vascular disease
• Patients taking sulfonylurea anti-diabetic agents at the time of transplant
• Patients taking nitrates at the time of transplant
• Body mass index \> 45
• Pregnant patients
• Patients in whom complete lower extremity ischemia is not achieved despite maximum tourniquet inflation to 250 mmHg during the first intervention
• Patients with lower extremity paralysis

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University - University Hospital

Newark, New Jersey, 07101-0820, United States

Location

Related Publications (25)

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MeSH Terms

Conditions

Liver Failure; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Limitations and Caveats

Two modifications resulted in a smaller number of subjects. Number of cycles, the duration of each cycle and the number of postoperative interventions were not addressed. Lack of randomization led to historical cohort to evaluate some outcomes.

Results Point of Contact

• Title: Baburao Koneru, MD, MPH
• Organization: Rutgers-NJ Medical School

koneruba@njms.rutgers.edu

973-972-9599

Study Officials

• Baburao Koneru, MD, MPH

  Rutgers University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Surgery

Study Record Dates

• First Submitted: December 6, 2015
• First Posted: December 18, 2015
• Study Start: November 1, 2015
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)