Novel Strategies for Innovating Deceased Donor Procurement

Kidney Failure, Chronic Clinical Trial

Official title:

Novel Strategies for Innovating Deceased Donor Procurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007017
• Other study ID #: 00071879
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 7, 2021

Study information

• Verified date: June 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Procedure:
• Deceased donor nephrectomy, prior to cross clamp of donor aorta
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.
• Deceased donor nephrectomy, standard of care
The investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Living Legacy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sequence of organ procurement	Renal allograft survival	1 year
Primary	Kidney quality	Incidence of delayed renal graft function	3 months