Compares fewer weekly dialysis sessions with standard care in kidney failure
Tests fewer weekly dialysis sessions against standard care in adults with kidney failure.
Plain-language title generated from the registry record
Registry title: RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)
Key facts
- Where
- Bari, ItalySee the site
Where in Italy
- Azienda Ospedaliero Universitaria Consorziale PoliclinicoBari, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Trial code
- NCT04360694
- Record updated
- 12 June 2024
- Original description
Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. The main problems related to prescription of incremental HD are an arbitrary use of infrequent regimens and the lack of clear standards for incorporating residual kidney function (RKF) in the assessment of HD dose. Several models have been proposed for prescription of incremental dialysis. The latest, the variable target model (VTM), gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF. Despite increasing evidence derived from observational studies to support the use of incremental HD, RCTs are lacking and, therefore, urgently needed.Read full original descriptionShow less
RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis
Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. The main problems related to prescription of incremental HD are an arbitrary use of infrequent regimens and the lack of clear standards for incorporating residual kidney function (RKF) in the assessment of HD dose. Several models have been proposed for prescription of incremental dialysis. The latest, the variable target model (VTM), gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF. Despite increasing evidence derived from observational studies to support the use of incremental HD, RCTs are lacking and, therefore, urgently needed.
Methods/Design:
The Department of Nephrology, Dialysis and Transplantation of the Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy and the EUDIAL Working Group of the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) are starting a randomized clinical trial (RCT) in incident HD patients, whose name is "REAL LIFE", by using the acronym of its whole definition: RandomizEd clinicAL triaL on the effIcacy and saFety of incremental haEmodialysis. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). The trial, originally conceived by experts at the Division of Nephrology of the Miulli General Hospital, Acquaviva delle Fonti, Italy, consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness.
Discussion: REAL LIFE will enable the investigators to know with the highest level of scientific evidence the safety and efficacy of an incremental approach to the start of HD treatment.
Inclusion: Adults aged > 18 years; Start of maintenance hemodialysis treatment due to advanced CKD stage 5D; Patients who are about to start HD or have already started HD within a period of ≤ 2 weeks; Glomerular filtration rate <= 10 mL/min/1.73 m2, as estimated by means of CKD-EPI formula.
Exclusion: Already treated with other replacement therapies (peritoneal dialysis or kidney transplant); Patients who are in the waiting list for a living kidney transplant; eGFR higher than 10 mL/min/1.73 m2; Associated diseases: active neoplastic disease; refractory congestive heart failure (type IV NYHA, ejection fraction ≤ 30%) requiring high ultrafiltration volumes per session; Age < 18 years; Acute kidney injury or acute on chronic kidney injury; UO < 600 mL/day; Unable or unwilling to give informed consent; Unable to comply with trial procedures, e.g., collection of UO; Likely survival prognosis or planned modality or centre transfer < 6 months.