Renal failure Urological and Genital Diseases Renal and Urogenital/ Renal failure
Conditions
Interventions
Participants in the intervention arm receive in-centre, high-volume, post-dilution HDF typically for four hours, three times a week. Participants in the control arm receive in-centre high-flux HD typi
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 and older receiving in-centre, maintenance HD or HDF for ESKD 2. Dialysing three times a week in a main dialysis unit or satellite unit 3. Potential to achieve high-volume HDF
Exclusion criteria
Exclusion criteria: 1. Lack of capacity to consent 2. Clinician predicted prognosis of less than 3 months 3. Started maintenance HD within the preceding 4 weeks 4. Transition to living kidney donor transplant or home dialysis scheduled within next 3 months 5. Not suitable for high-volume HDF for other clinical reasons such as dialysis less than thrice weekly or unlikely to achieve sufficient blood flow rates with current vascular access 6. Treatment with HDF for more than 3 months prior to inclusion in the trial or prior intolerance of HDF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Non-cancer mortality or hospital admission with a cardiovascular event or infection from randomisation to end of follow-up 2. A composite of first of non-cancer mortality or admission to hospital related to a cardiovascular event or infection is measured using datasets (UKRR, Hospital Statistics & ONS) from randomisation to end of follow-up (32-50 months depending on recruitment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All-cause mortality, cardiovascular and infection related morbidity and mortality. Health-related quality of life (QoL), cost effectiveness and environmental impact 2. All-cause mortality is measured using datasets (UKRR and ONS) from randomisation to end of follow-up (32-50 months depending on recruitment) 3. Cardiovascular – cause specific hospitalisation and mortality is measured using datasets ((UKRR, Hospital Statistics (HES, PEDW, ISD, NISRA) & ONS) from randomisation to end of follow-up (32-50 months depending on recruitment) 4. Infection – cause- specific hospitalisation and mortality using datasets (MRSA & MSSA) (Public Health England) from randomisation to end of follow-up (32-50 months depending on recruitment) 5. Health-related quality of life (QoL) – quality adjusted life years gained (EQ-5D-5L), generic quality of life (SF-36), disease specific (kidney symptoms within KDQOL-36) and time to recover after dialysis: From Patient Questionnaires - assessed using repeated measures taken six-monthly 6. Cost effectiveness and environmental impact (including locally purified water, manufactured saline and plastic consumables): using all available data for the full duration of follow-up (32-50 months) | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactSunita Procter
Outcome results
None listed