Kidney Disease Clinical Trial
— RIPCOTOfficial 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.
Status | Completed |
Enrollment | 85 |
Est. completion date | June 2014 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years and older |
Eligibility |
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). DONORS Exclusion Criteria: - 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: - All recipients of solid organ pancreas (isolated pancreas transplant or combined kidney pancreas transplant) from deceased donors enrolled in this study and who receive their transplants at one of the four pancreas transplant centers in New Jersey, HUH, SBMC, RWJUH and OLMC. NBIMC and UH do not perform pancreas transplantation Exclusion Criteria - Islet cell transplant recipients - Recipients of deceased donor whole organ pancreas imported from outside NJ - Recipients of pancreas from deceased donors < 5 years of age - Recipients of pancreata from deceased donors not enrolled in the study due to logistical reasons |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University Hospital | Newark | New Jersey |
Lead Sponsor | Collaborator |
---|---|
University of Medicine and Dentistry of New Jersey |
United States,
Ali ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SA, Akthar AM, Boyle JR, Varty K, Kharbanda RK, Dutka DP, Gaunt ME. Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial. Circulation. 2007 Sep 11;116(11 Suppl):I98-105. — View Citation
Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. Epub 2006 May 15. — View Citation
Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. — View Citation
Hoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, Clarke SC, Shapiro LM, Schofield PM, O'Sullivan M, Dutka DP. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial. Circulation. 2009 Feb 17;119(6):820-7. doi: 10.1161/CIRCULATIONAHA.108.809723. Epub 2009 Feb 2. — View Citation
Kanoria S, Jalan R, Seifalian AM, Williams R, Davidson BR. Protocols and mechanisms for remote ischemic preconditioning: a novel method for reducing ischemia reperfusion injury. Transplantation. 2007 Aug 27;84(4):445-58. Review. — View Citation
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---|---|---|---|---|
Primary | Organ Recovery | Organs Recovered and Transplanted per donor | 1 week | No |
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