Urological and Genital Diseases Urological and Genital Diseases
Conditions
Interventions
Patients starting haemodialysis as an outpatient who still have some remaining kidney function will be invited to participate in a clinical trial that compares current best practice with the same but
Sponsors
Keele University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged >18 years commencing centre-based maintenance haemodialysis due to advanced kidney disease CKD stage 5, planned or unplanned, via arterio-venous fistula, graft or central venous catheter (i.e. with or without permanent vascular access) 2. Commencing dialysis on any regimen, including having incremental dialysis initiation 3. Residual kidney function: For patients who have not yet started dialysis treatment they should have a daily urine volume > 500ml/day and/or a or a measured mean urea and creatinine clearance >3ml/min/1.72m2 determined from a 24 hour collection; for patients already on dialysis they should have a urine volume >500ml during the short inter-dialytic period and/or a measured mean urea and creatinine clearance >3ml/min/1.72m2, determined from the same timed inter-dialytic urine collections and an average of the post- and pre-dialysis plasma urea and creatinine concentrations.
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to give informed consent 2. Unable to comply with trial procedures, e.g. collection of urine output 3. Likely survival prognosis or planned modality transfer < 6 months 4. Subjects with limb amputations when the foot is not accessible AND it is not possible to take hand to hand measurements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to anuria ( loss of urine output), <100ml/day or 200ml in the short inter-dialytic period confirmed by a further collection after 2 weeks to exclude temporary illness. To measure the primary outcome urine volume and residual renal clearances to be measured at baseline, monthly for 3 months and alternate months (for up to a further 20 months) until trial completion, or the primary endpoint is reached. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determining the effect of the use of bioimpedance in assessing the amount of fluid in the body to guide the setting of the post-dialytic target weight on: 1. The rate that kidney function reduces ( baseline, monthly for 3 months, then alternate months for up to 20 months) 2. Vascular access failure, cardiovascular events, hospital admissions, death and including the use of routinely collected data from the UK Renal Registry, Hospital episode Statistics and the Office for National Statistics (and equivalent bodies in Wales, Scotland and Northern Ireland) via the UK Renal Registry. These are measured at baseline, and at the end of the study, routine clinical data collected by dialysis units for the UK Renal Registry returns will be made available for this study. Death will be recorded in real time during the study 3. Measures of dialysis efficacy and safety (body fluid assessment, blood pressure). These are measured at baseline, monthly for 3 months, then every 3 months for up to a further 20 months 4. Patient reported outcomes including quality of life, dialysis symptoms, functional status. These are measured at baseline, then 3 monthly for up to 24 months | — |
Countries
England, United Kingdom
Outcome results
None listed