Remote Ischemic Preconditioning In Abdominal Organ Transplantation

Completed · Phase 3

Conditions studied: Kidney Disease, Liver Disease, Pancreas Disease

In brief

Does remote ischemic preconditioning (RIPC) induced by a brief period of occlusion of blood flow to the lower extremity prior to organ recovery in deceased donors, improve short and long term outcomes after transplantation of kidneys, livers and pancreas? To test this hypothesis deceased organ donors will be randomized to receive either RIPC or No RIPC before organ recovery. RIPC will be induced in the operating room after commencement of procurement surgery. RIPC will be induced by tourniquet-induced occlusion of blood flow to the lower extremity for 10 minutes in each side, for a total duration of 20 minutes. The remainder of the organ recovery and organ preservation will be as per standard of practice. Recovered livers, kidneys and pancreas will be transplanted into allocated recipients. Transplantation and patient management after transplantation will be as per standard of practice. Organ-specific function and cell injury parameters will be utilized to assess the early postoperative outcomes of individual organs and recipients. Long term outcomes will be assessed by graft and recipient survival.

Key facts

Study ID

NCT00975702

Run by

University of Medicine and Dentistry of New Jersey

People needed

85

Starts

2009-04-01

Expected to finish

2014-06-01

Last updated by the study team

2015-01-14

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All deceased organ donors aged > 5 years in acute care hospitals in the donor service area of the New Jersey Organ and Tissue Sharing Network (NJTO).
• DONORS

You may not qualify if…

• Tissue only donors
• Age < 5 years
• When it is known before organ recovery that both kidneys will be leaving New Jersey. This may happen in a few instances either because of excellent tissue match with recipients outside New Jersey or in high risk behavior donors where all NJ kidney transplant centers have declined donor kidneys before organ recovery
• Deceased donors in whom a decision is made not to recover both kidneys (severe kidney disease, renal failure, etc)
• Severe trauma to both lower extremities precluding induction of RIPC
• RECIPIENTS - KIDNEY
• Inclusion Criteria:
• Patients who receive a kidney from an enrolled donor at one of the five kidney transplant centers in New Jersey, HUH, NBIMC, SBMC, RWJUH and OLMC. No kidney recipients will be enrolled at UH because UH does not perform isolated kidney transplantation.
• Exclusion Criteria :
• All live donor kidney transplants performed at participating kidney transplant centers
• Recipients of deceased donor kidneys imported from outside NJTO
• Recipients of kidneys from deceased donors < 5 years of age
• Recipients of combined liver and kidney transplantation, which are performed only at UH and OLMC. The numbers of such transplants are very few per year (<5). Also, the clinical and pathophysiological issues are different from those requiring isolated kidney transplantation
• Recipients of en bloc (both kidneys together into one recipient) kidney transplantation from study donors. It is anticipated that such instances will be very few per year (<5)
• Recipients of kidneys from deceased donors not enrolled in the study due to logistical reasons.
• RECIPIENTS - LIVER
• Inclusion Criteria:
• All recipients of livers from deceased donors enrolled in this study and who receive their transplants at either of the two liver transplant centers in New Jersey, UH or OLMC.
• Exclusion Criteria:
• Live donor recipients
• Recipients of livers imported from outside NJTO
• Recipients of deceased donor livers from donors < 5 years of age
• Recipients of livers from deceased donors not enrolled in the study due to logistical reasons
• RECIPIENTS - PANCREAS
• Inclusion Criteria:

Where it is running

• University Hospital — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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