Delayed Graft Function
Conditions
Keywords
Kidney Transplant, Delayed Graft Function, Donor-Derived Cell-Free DNA
Brief summary
This is a prospective multicenter nonrandomized pragmatic hybrid effectiveness-implementation study to test the effectiveness of TxAccess in improving time to renal recovery and immunologic outcomes in patients with delayed graft function (DGF) and to assess barriers and facilitators to implementation of TxAccess in the post-transplant care period. Research blood will be collected for donor-derived cell-free DNA testing, and patient questionnaires will be administered.
Interventions
DEVICETxAccess
Software platform facilitating communication between transplant centers, nephrology practices, and dialysis facilities.
DIAGNOSTIC_TESTDonor-Derived Cell-Free DNA (dd-cfDNA)
Blood testing to assess allograft injury and immunologic outcomes.
Sponsors
Duke University
CareDx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study Population: Patients Inclusion criteria: Adult patients who experienced delayed graft function after a deceased donor kidney transplant in the last 2 calendar years
Exclusion criteria
Patients younger than 18 years old at the time of transplant; patients who experienced graft loss prior to discharge from their index hospitalization patients who receive outpatient dialysis at a center that does not utilize TxAccess (intervention period) Study Population: Clinicians Inclusion criteria: adult clinicians who participate in care of kidney transplant recipients, including surgeons, nephrologists, pharmacists, social workers, nurse coordinators, advanced practice providers, nurses, case managers and dialysis center clinicians and staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed Graft Function (DGF) severity, defined as time to freedom from dialysis | through 90 days post-transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Allograft biopsy rate | first post transplant year | Number of allograft biopsies |
| Health Care Resource Utilization (hospital length of stay) | first post transplant year | Hospital length of stay |
| Health Care Resource Utilization (readmission rate) | first post transplant year | Hospital readmission rate |
| Health Care Resource Utilization (days in intensive care unit) | first post transplant year | Days in the intensive care unit |
| Dialysis utilization | 90 days after transplant procedure | number of dialysis sessions |
| Health care related quality of life | 90 days after transplant procedure | Change in PROMIS measures |
Contacts
PRINCIPAL_INVESTIGATORLisa McElroy
Duke University
Outcome results
None listed