Clinical Trial: Deceased Organ Donor Interventions to Protect Kidney Graft Function
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Mild Hypothermia Versus Pulsatile Perfusion in Deceased Donors and Kidney Graft Function
Brief Summary: To protect kidney function during the transplantation process by comparing mild hypothermia in the deceased organ donor before organs are recovered and pulsatile perfusion of the kidney while being transported to the recipient.
Detailed Summary:
The number of kidneys available for transplantation in the U.S. (~15,000/yr) does not meet demand (~80,000/yr). This discrepancy will likely worsen given the increasing U.S. prevalence of chronic kidney disease and is compounded by sizable organ attrition once organs have entered the donation process (25-30% attrition in Region 5). Furthermore, worsening renal function in donation after neurologic determination of death (DNDD) organ donors (an increasingly important source of allografts) is one of the strongest predictors of delayed graft function (DGF) and slow graft function (SGF) in the recipient. Both DGF and SGF are associated with decreased long-term organ survival and are of major concern to the transplant community.
The investigators will accomplish this goal by extending an existing research infrastructure across several donor service areas. Infrastructure and logistics will be based on the investigators' successful completion of NCT01680744.
Sponsor: University of California, San Francisco
Current Primary Outcome: Delayed Graft Function in Kidney Allografts [ Time Frame: 7 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient and Allograft survival [ Time Frame: 1 year and 3 years ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: August 6, 2015
Date Started: November 2015
Date Completion: March 2019
Last Updated: August 14, 2015
Last Verified: August 2015
