Kidney Disease Clinical Trial
Official title:
Phase III Study of Efficacy of Remote Ischemic Preconditioning in Improving Outcomes in Organ Transplantation
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.
Deceased organ donors and recipients of kidneys, livers and pancreata from the study donors
comprise the study subjects.
I. DONORS
I. A. Inclusion Criteria 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).
I.B. Exclusion criteria
1. Tissue only donors
2. Age < 5 years
3. When it is known before organ recovery that both kidneys will be leaving New
JerseyIntervention: RIPC will be induced by inflation of a tourniquet around the upper
thigh to 200 mm of Hg for a period of 10 minutes. After tourniquet deflation on one
side, a similar procedure will be followed immediately on the opposite side. Thus, a
total period of 20 minutes of lower extremity vascular occlusion will be utilized to
induce RIPC. In instances of severe trauma to one lower extremity precluding tourniquet
use, we will employ two cycles of 10 minutes of tourniquet occlusion in the
non-traumatized lower extremity with 10 min of reperfusion in between. RIPC will be
induced after commencement of procurement surgery but completed 30-45 min before
circulatory arrest and initiation of organ perfusion.
Additionally, liver biopsies (a wedge measuring 0.75 x 0.75 cm and a Tru-cut needle
biopsy from the right lobe) are performed in as soon as the abdomen is opened. A wedge
(1 x 0.3 cm) kidney biopsy is performed in all donors after kidney recovery but before
packing the organs. All biopsies except kidney biopsies in donors aged < 50 years, are
as per standard of care. The remainder of organ recovery, organ packaging and
preservation are as per standard of practice. All kidneys recovered from donors
classified as Extended Criteria Donors (donor age > 60 years or age 50-59 years with
two of the following three criteria- cerebrovascular cause of death, a history of
hypertension, terminal serum creatinine > 1.5 mg/dL) are routinely perfused ex-vivo in
a pulsatile hypothermic perfusion apparatus until transplantation.
. 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
4. Deceased donors in whom a decision is made not to recover both kidneys (severe kidney
disease, renal failure, etc)
5. Severe trauma to both lower extremities precluding induction of RIPC
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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