Prevalent patients on hemodialysis Other
Conditions
Interventions
This study primarily aims to determine the efficacy and safety of dialysis therapy in two real-life cohorts, one with hemodialysis using high-flux dialyzers (HD HF) and the other with expanded hemodia
RTS Soacha, RTS Agencia San Rafael
RTS National University agency, RTS Nationa
Sponsors
Baxter (United States)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients 18 years of age and older 2. Patients diagnosed with chronic kidney disease (CKD) in renal failure with more than 90 days of chronic hemodialysis 3. Receiving HD at least 3 times per week for a minimum of 4 hours per session 4. Be treated at one of the 6 renal clinics selected to participate in this study 5. Have a vascular access arteriovenous fistula or graft
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. High comorbidity as measured by Charlson Comorbidity Index > 8 and patients not expected to survive more than 6 months 3. Metastatic disease 4. Patients with sensory or cognitive impairment that prevents them from responding to the surveys. 5. Patient who does not provide informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effectiveness measured using the reduction ratio of Beta-2 microglobulin in serum measured using the Immunoturbidimetric test at week 4 and week 12 2. Effectiveness measured using the reduction ratio of Kappa-free light chains in serum measured using turbidimetry technique at week 4 and week 12 3. Effectiveness measured using the reduction ratio of Lambda free light chains in serum measured using turbidimetry technique at week 4 and week 12 4. Effectiveness measured using the reduction ratio of leptin in serum measured using ELISA test at week 4 and week 12 5. Change from a baseline value of Kt/V single pool, hemoglobin, phosphorus, iPTH, serum albumin and high-sensitivity CRP measured using means difference at 4, 8, and 12 weeks of follow-up 6. The incidence of adverse events and serious adverse events measured according to the International Classification for Patient Safety 1.0 of the Global Alliance for Patient Safety WHO, adapted to Colombia. Events data collected in study records during follow-up. Where the numerator is made up of the number of adverse events and the denominator is made up of the total number of patients at risk. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: 1. Post-hemodialysis session recovery time measured using data collected from patient medical records at baseline, 4, 8, and 12 weeks 2. Pruritus measured using the Pruritus scale at baseline and 12 weeks 3. Restless legs syndrome measured using the Diagnostic criteria for restless legs at baseline and 12 weeks 4. Quality of life measured using the KDQoL SF 36 and EQ-5D-5L instruments at baseline and 12 weeks 5. Physical, mental, and social health reported by patients with the PROMIS 29 instrument at baseline and 12 weeks Exploratory Evaluations: 1. Non-fatal cardiovascular events and mortality measured using data collected from patient medical records during follow-up 2. Resource use for the HD AF or HDx procedure from the provider's perspective. Case methodology will be used to establish the direct cost of a hemodialysis session with an HF dialyzer using a dialysate flow of 400 and 500 ml/hour and it will be compared with the cost of performing an expanded hemodialysis session with a Theranova dialyzer. | — |
Countries
Colombia
Contacts
Public ContactJuan Carlos Mario Castillo
Outcome results
None listed