Haemodialysis, renal failure Urological and Genital Diseases Haemodialysis (or haemodiafiltration), kidney dialysis, kidney failure, renal failure
Conditions
Interventions
Current intervention as of 14/05/2021:
Participants will be randomised to either:
1. Intervention arm where participants will receive 6 - 8 h of in-centre haemodialysis delivered overnight, 3 times p
8 units initiated at 12 months
2. Randomise an average of 12 patients per unit in the first quarter (i.e. 6 patients will start in-centre nocturnal dialysis)
96 participants randomised at 12 months
3. Experience a maximum 25% drop out rate in the first 2 weeks of starting in patients randomised to in-centre nocturnal dialysis
participant drop out in first 2 weeks of nocturnal dialysis is <25% at 12 months
4. Encounter a dropout rate of no more than 15% across the two study arms as a result of death, kidney transplantation
remaining loss to follow-up is
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients established on haemodialysis for =3 months (i.e. prevalent dialysis patients) 2. Aged =18 years 3. Able to give informed consent 4. Able to participate fully in the interventions and follow-up procedures
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 14/05/2021: 1. Currently on in-centre nocturnal dialysis, or less than 3 months since stopping 2. Less than 3 months since stopping daily extended daytime or nocturnal dialysis 3. Patients for whom extended dialysis is clinically indicated (e.g. calciphylaxis, pregnancy) 4. Scheduled for living donor kidney transplant 5. Plans to change dialysis modality or centre in the next 6 months 6. Life expectancy of <6 months 7. Current participation in an interventional trial with conflicting therapies or primary outcomes _____ Previous exclusion criteria: 1. Currently on in-centre nocturnal dialysis, or less than 3 months since stopping 2. Less than 3 months since stopping daily extended daytime or nocturnal dialysis 3. Patients for whom extended dialysis is clinically indicated randomisation to standard hours care of 4 h thrice weekly during the day would be clinically unacceptable (e.g. calciphylaxis, pregnancy) 4. Scheduled for living donor kidney transplant 5. Plans to change dialysis modality or centre in the next 6 months 6. Life expectancy of <6 months 7. Current participation in an interventional trial with conflicting therapies or primary outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 17/02/2023: Kidney Disease Quality of Life (KDQoL) total score (calculated from the KDQoL-SF questionnaire) measured over 6 months _____ Previous primary outcome measure: Quality of life measured using the composite score from the Kidney Disease Quality of Life tool (KDQoL) at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 17/02/2023: 1. Kidney Disease Quality of Life (KDQoL) total score (calculated from the KDQoL-SF questionnaire) measured at 1-, 3- and 6-months 2. Kidney Disease Quality of Life (KDQoL) domains (calculated from the KDQoL-SF questionnaire) measured over 6-months 2.1. Physical component summary score 2.2. Mental component summary score 2.3. Kidney summary score 2.4. Kidney disease component summary score 3. Additional Patient Reported Outcome Measures assessed at baseline, 1, 3 and 6 months: 3.1. Health-related quality of life measured using the EQ-5D-5L 3.2. Levels of fatigue measured using the SONG Haemodialysis Fatigue measure 3.3. Sleep quality measured using the Pittsburgh Sleep Quality Index 3.4. Time to recovery after dialysis measured using a simple question on Time to Recovery (TTR) in minutes after dialysis 3.5. Cognitive health assessed using the Montreal Cognitive Assessment at baseline, 3 months and 6 months 4. Safety measures: 4.1. Residual kidney function measured using urine collection with paired blood samples taken at the time of dialysis to give standard measures of urine volume, urea and creatinine clearance at baseline and 6 months, and serum beta-2 microglobulin in blood samples taken monthly between baseline and 6 months 4.2 Serious adverse events (SAEs) 4.2.1. SAEs in totality (rate/years) 4.2.2. Vascular access complications that lead to SAEs (rate/years) 4.2.3. Dialysis prescription changes that lead to SAEs (rate/years) 4.3. Clinical outcomes (cardiovascular events, CVD death, mortality) (rate/years) collected using Hospital Episode Statistics (HES) and Office of National Statistics (ONS) databases (or regional equivalent) on the three year anniversary of the last participant last visit 5. Measures of process: 5.1. Adherence to the intervention 5.1.1. Hours per session 5.1.2. Number of sessions missed 5.1.3. Number of sessions not meeting time criteria 5.1.4. Temporary change from treatment allocatio | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactNiamh Quann
Outcome results
None listed