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Novel Strategies for Innovating Deceased Donor Procurement

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deceased donor nephrectomy, prior to cross clamp of donor aorta
Deceased donor nephrectomy, standard of care
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Sequence of organ procurement
Renal allograft survival
Kidney quality
Incidence of delayed renal graft function

Secondary Outcome Measures

Full Information

First Posted
December 8, 2016
Last Updated
June 7, 2021
Sponsor
University of Maryland, Baltimore
Collaborators
Living Legacy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03007017
Brief Title
Novel Strategies for Innovating Deceased Donor Procurement
Official Title
Novel Strategies for Innovating Deceased Donor Procurement
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 7, 2021 (Actual)
Study Completion Date
June 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Living Legacy Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patients selected for this arm will receive the left kidney from the new method of organ retrieval.
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Patients selected for this arm will receive the normal standard of care operational kidney from retrieval.
Intervention Type
Procedure
Intervention Name(s)
Deceased donor nephrectomy, prior to cross clamp of donor aorta
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Deceased donor nephrectomy, standard of care
Intervention Description
The investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation
Primary Outcome Measure Information:
Title
Sequence of organ procurement
Description
Renal allograft survival
Time Frame
1 year
Title
Kidney quality
Description
Incidence of delayed renal graft function
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently listed to receive a deceased donor kidney transplant Able to fully understand the informed consent document Recipient over the age of 18 years Exclusion Criteria: Recipients undergoing a bilateral native nephrectomy at time of transplant Recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc) transplant Individuals who are unable to understand the informed consent document Recipient under age 18 years Recipients receiving desensitization protocols for high levels of donor specific antibodies
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Novel Strategies for Innovating Deceased Donor Procurement

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