Adequacy of Haemodiafiltration: Middle Molecules Clearance, Patients Reported Outcomes and Sodium Balance

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEast and North Hertfordshire NHS Trust

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 4 trial groups
Group A: HDF group
Group B: HD group
Group C: Low dialysate sodium group
Group D: High dialysate sodium group

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
5 years

Other outcomes

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