About this trial
The goal of this observational study is to understand the differences in terms of middle molecules clearance and patient outcomes in High (\>23Litres (L)) vs Low (\<23 L) convection volume (CV) Hemodiafiltration (HDF) and to understand the effect of dialysate fluid sodium concentration (137 vs 140 mmol/L) on overhydration volume in patients on HD and HDF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or above.
Ability to give informed consent.
End stage kidney disease (ESKD) treated by haemodialysis for at least 3 months.
Prognosis > 6 months as assessed by principal investigator (PI)
Disqualifiers
None
Trial population
Adult patients with ESKD receiving hemodialysis accross 5 dialysis units in East and North Hertfordshire NHS Trust , UK.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Effect of high (≥23L) versus low volume HDF (<23L) on middle molecules clearance and on clinical and patients reported outcomes.
1. Effect of high (≥23L) versus low volume HDF (\<23L) on β2M clearance. 2. Effect of high (≥23L) versus low volume HDF (\<23L) on dialysis related symptom score (measured using IPOS-Renal questionnaire). 3. Effect of high (≥23L) versus low volume HDF (\<23L) on cognitive function (Assessed using PROMIS cognitive function short form). 4. Effect of high (≥23L) versus low volume HDF (\<23L) on malnutrition score (Measured using modified subjective global assessment tool). 5. Effect of high (≥23L) versus low volume HDF (\<23L) on serum phosphate level (mmol/L). 6. Effect of high (≥23L) versus low volume HDF (\<23L) on phosphate binder dose (mg/day). This will be measured cross-sectionally at 0,6 and 12 month time points and longitudinally over time correcting for variables including residual renal function.
Effect of dialysis fluid sodium concentration of (137 vs 140 mmol/L) on overhydration volume in patients on HD and HDF.
Effect of dialysis fluid sodium concentration of (137 vs 140 mmol/L) on overhydration volume (measured with Bioimpedance) in patients on HD and HDF. This will be assessed cross-sectionally at 0,6 and 12 months and also longitudinally over time correcting for confounding variables such as RKF.
Secondary outcomes
Correlation between middle molecule clearance (β2M clearance) with rate of major adverse cardiovascular events (non-fatal MI, Non-fatal stroke, cardiovascular death) and all cause hospitalizations.
Correlation between middle molecule clearance (β2M clearance) with rate of major adverse cardiovascular events (non-fatal MI, Non-fatal stroke, cardiovascular death) and all cause hospitalizations.
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