Kidney transplantation Urological and Genital Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients undergoing DCD kidney transplantation (Maastricht Categories III & IV) 2. DCD donor aged 18 years or over 3. Transplant recipients aged 18 years or over 4. First or second kidney transplant recipients
Exclusion criteria
Exclusion criteria: 1. DCD donors aged under 18 years 2. DCD donors in Maastricht Categories I & II 3. Third and subsequent kidney transplant recipients 4. Multi-organ transplants e.g. simultaneous pancreas-kidney transplantation 5. Dual kidney transplants 6. Paediatric en-bloc kidney transplants 7. Organ preservation by hypothermic machine perfusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed graft function rate is determined by the need for dialysis in the first 7 days post-transplant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Primary non-function (PNF), defined as the permanent lack of allograft function from the time of transplantationincluding graft losses due to irreversible rejection and vascular thrombosis, is recorded along with the cause at the end of the trial (12 months) 2. Duration of DGF is measured by recording the number of sessions and days that the recipient requires dialysis after transplantation in days 3. Functional DGF (fDGF), defined as <10% fall in serum creatinine for 3 consecutive days, is measured using blood analysis in the first week post-transplant 4. Creatinine reduction ratio (CRR2 = creatinine day 1 – creatinine day 2/ creatinine day 1) is measured using blood analysis on day 2 5. Creatinine reduction ratio (CRR 5 = pre transplant creatinine - creatinine day 5/ pre-transplant creatinine) is measured using blood analysis on day 5 6. Length of hospital stay is measured as the number of days the recipient remains in hospital after the transplant 7. Biopsy-proven acute rejection rates is measured through examination of kidney biopsy samples when acute rejection is suspected 8. Serum creatinine and eGFR is measured using blood and urine analysis at baseline (pre-transplant), 1, 3, 6 and 12 months 9. Patient survival (time from transplant to death) is measured in days 10. Allograft survival (time from transplant to graft loss or return to dialysis) is measured in days | — |
Countries
England, United Kingdom