Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study
Completed · Not applicable
Conditions studied: Liver Failure, Carcinoma, Hepatocellular
In brief
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.
Key facts
- Study ID
- NCT02635347
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 31
- Starts
- 2015-11-01
- Expected to finish
- 2017-12-31
- Last updated by the study team
- 2019-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Rutgers University - University Hospital — Newark, New Jersey, United States
Full record on ClinicalTrials.gov
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