Renal Dialysis
Conditions
Interventions
This is a randomized controlled clinical trial with two arms, unmasked. A total of 50 patients who meet the eligibility criteria will be probabilistically allocated to one of two intervention groups u
E02.870.300.200
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Individuals of both genders; age over 18 years and under 75 years; undergoing daily Hemodiafiltration due to stage five chronic kidney disease; clinically stable in the last three months; adherence to treatment of at least eighty percent in the last three months; written informed consent provided
Exclusion criteria
Exclusion criteria: Presence of clinically relevant acute infectious diseases; active cancer; recent cardiovascular instability such as myocardial infarction or decompensated heart failure; clinical conditions that may interfere with result interpretation or treatment adherence; severe psychiatric conditions that may compromise adherence or result interpretation; pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of different dialysate flow rates in the clearance of urea, ß2-microglobulin, and free light chains Kappa and Lambda. Clearance will be measured using stKt/V for urea, Kt/V for ß2-microglobulin, and the percentage reduction of Kappa and Lambda chains. Comparisons will be made between groups over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the amount of water used per session, calculated by the formula: water volume = 0.94 × total dialysate volume per session × number of sessions per week. Group comparisons will be made based on the total volume consumed at 12 and 24 weeks.;To evaluate the cost of water used during hemodiafiltration sessions, calculating the cost difference between groups based on the total water bill and volume consumed over 24 weeks.;To monitor pre-dialysis levels of phosphorus, calcium, potassium, sodium, and parathyroid hormone, as well as the need for therapy adjustments. Hemoglobin and hematocrit levels will also be monitored, along with the use of erythropoiesis-stimulating agents. Adverse events such as blood pressure instability, calciphylaxis, and uremic symptoms (nausea, loss of appetite, weight loss, pruritus) will be tracked, and their frequency will be observed in both groups. | — |
Countries
Brazil
Contacts
Public ContactFelipe Pascoal
Centro Brasiliense de Nefrologia e Diálise
Outcome results
None listed