An interventional study of Deceased donor nephrectomy, prior to cross clamp of donor aorta and Deceased donor nephrectomy, standard of care in Kidney Failure, Chronic, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-09.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Health services research
Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys available for transplantation and the number of patients on the transplant waiting list. Increasing the quality of currently available donor kidneys would potentially improve the longevity of deceased donor kidney transplants by years, thus increasing the rate of transplantation patients on the kidney transplant waiting list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower total hospital charges. By innovating the organ donation process, such that deceased donor kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be possible to improve the quality of the kidney before transplantation, resulting in improved function after transplantation and increased longevity of these transplanted kidneys. Further, this improved kidney quality is highly likely to translate to reduced need for renal dialysis and other high-cost interventions, yielding lower total hospital charges. In this study we will test the hypothesis that, through a cost-free technical innovation, the quality of deceased donor kidneys could be improved significantly, saving thousands more lives per year and reducing total health care expenditures on renal transplantation.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 2 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Exclusion Criteria:
Patients selected for this arm will receive the left kidney from the new method of organ retrieval.
Procedure: Deceased donor nephrectomy, prior to cross clamp of donor aorta
Patients selected for this arm will receive the normal standard of care operational kidney from retrieval.
Procedure: Deceased donor nephrectomy, standard of care
The investigators will perform a prospective investigation of organ recoveries during which the left kidney will be removed prior to cessation of cardiac activity. The second kidney will be removed in the standard fashion. To do this, investigators will adopt techniques used in living donor kidney transplantation. Specifically, a specialized vascular stapler will be used to divide the renal artery at the level of aorta, followed by the vein, at the level of the vena cava. As such, no "cuff" of abdominal aorta or vena cava will be present on the target kidneys. Once removed from the body, just as is done for living donor kidney transplantation, the kidneys will be immediately flushed. As this ex-vivo flush is already performed for cadaveric kidney transplantation, there should be no additional cost for performing this portion of the procedure. Approximately 15 minutes of additional surgical dissection (prior to stopping the heart) will be required under the proposed study.
The investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation
Sequence of organ procurement
Renal allograft survival
Time frame: 1 year
Kidney quality
Incidence of delayed renal graft function
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore