Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer, Neurology, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2015 |
| End Date: | June 2017 |
| Contact: | Baburao Koneru, MD, MPH |
| Email: | koneruba@njms.rutgers.edu |
| Phone: | 973-972-9599 |
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.
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.
Orthotopic liver transplantation (OLT) is associated with a very high risk of complications.
In a recent multi-center study of 450 patients, 79% had at least one complication and 63%
had severe (Clavien-Dindo grade III or higher) complications. The number and severity of
complications are associated with death within 30 days, hospital length of stay, graft and
patient survival. Infections are the most common group of complications, followed by
pulmonary, renal and liver graft dysfunction. Interventions that decrease these
complications after OLT are likely to improve clinical outcomes.
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.
In a recent multi-center study of 450 patients, 79% had at least one complication and 63%
had severe (Clavien-Dindo grade III or higher) complications. The number and severity of
complications are associated with death within 30 days, hospital length of stay, graft and
patient survival. Infections are the most common group of complications, followed by
pulmonary, renal and liver graft dysfunction. Interventions that decrease these
complications after OLT are likely to improve clinical outcomes.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- < 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
- History of peripheral neuropathy
- 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
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