Novel Strategies for Innovating Deceased Donor Procurement

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Kidney Failure, Chronic

Treatments: Procedure: Deceased donor nephrectomy, standard of care; Procedure: Deceased donor nephrectomy, prior to cross clamp of donor aorta

Study type: Interventional

Funder types: Other

Identifiers

NCT03007017

00071879

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Currently listed to receive a deceased donor kidney transplant
2. Able to fully understand the informed consent document
3. Recipient over the age of 18 years

Exclusion criteria

1. Recipients undergoing a bilateral native nephrectomy at time of transplant
2. Recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc) transplant
3. Individuals who are unable to understand the informed consent document
4. Recipient under age 18 years
5. Recipients receiving desensitization protocols for high levels of donor specific antibodies

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Arm 1

Experimental group

Description:

Patients selected for this arm will receive the left kidney from the new method of organ retrieval.

Treatment:

Procedure: Deceased donor nephrectomy, prior to cross clamp of donor aorta

Arm 2

Active Comparator group

Description:

Patients selected for this arm will receive the normal standard of care operational kidney from retrieval.

Treatment:

Procedure: Deceased donor nephrectomy, standard of care