End Stage Kidney Disease renal insufficiency
Conditions
Interventions
Patients will be randomised between high-dose HDF and high-flux HD treatment.
Both are currently approved methods of dialysis.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed and dated written Informed Consent Form. 2. Male or female aged >= 18 years. 3. Diagnosed with ESKD. 4. On HD treatment for >= 3 months. 5. Likely to achieve high-dose HDF (>= 23 L adjusted to BSA/session, in post-dilution mode) 6. Willing to have a dialysis session with duration of >= 4 hours, three times a week. 7. Understands study procedures and is able to comply.
Exclusion criteria
Exclusion criteria: 1. Severe subject non-compliance defined as severe non-adherence to the dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment. 2. Life expectancy = 3 months during the study conduct for study visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as difference in rate for all-cause mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1. Cause specific mortality (at least cardiovascular and non-cardiovascular death; others with high frequency may be added); 2. Non-fatal and fatal cardiovascular events; 3. Hospitalisation for infection-related conditions; 4. All cause hospitalisations; 5. patient related experience and outcome measures; 6. Cost effectiveness. | — |
Countries
Netherlands
Outcome results
None listed