Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study
NCT ID: NCT02635347
Last Updated: 2019-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2015-11-30
2017-12-31
Brief Summary
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Detailed Description
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Remote ischemic conditioning is an innate biological phenomenon wherein a brief single or repetitive ischemic stimulus in an organ or tissue such as skeletal muscle induce protection in remote/distant organs against ischemia and other noxious stimuli. This effect can be induced by inflating a pneumatic tourniquet on a leg or arm for a few minutes (usually 5-10) and subsequently deflating to allow reperfusion. This process is usually repeated 3-4 times to ensure an adequate dose of the conditioning stimulus. The conditioning stimulus could be applied before (Preconditioning), concurrent with (Perconditioning), or soon after the index noxious/ischemic insult (Postconditioning).
The goal of this study is to assess the feasibility, patient acceptance, and safety of RIC in liver recipients. In addition, the investigators will obtain data on posttransplant complications. Information obtained from this study will help guide the design of a future randomized, controlled trial to test the benefit of RIC in liver recipients.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Remote Ischemic Conditioning (RIC) group
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
Remote Ischemic Conditioning (RIC)
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.
Pneumatic tourniquet
Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions.
Interventions
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Remote Ischemic Conditioning (RIC)
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.
Pneumatic tourniquet
Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions.
Eligibility Criteria
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Inclusion Criteria
* Both sexes
* Written consent to participate in the study
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Baburao Koneru, MD, MPH
Professor, Department of Surgery
Principal Investigators
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Baburao Koneru, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Rutgers University
Locations
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Rutgers University - University Hospital
Newark, New Jersey, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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Pro20150002276
Identifier Type: -
Identifier Source: org_study_id
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