Renal replacement therapy Urological and Genital Diseases
Conditions
Interventions
Randomised cross-over study of three hemodialysis modalities: low-flux haemodialysis, high-flux hemodialysis and on-line haemodiafiltration
Sponsors
Beauséjour Medical Research Institute (L'Institut de Recherche Médicale Beauséjour) (IRMB) (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Chronic end-staged renal diseased (ESRD) patients on haemodialysis
Exclusion criteria
Exclusion criteria: 1. Hemodialysis for less than 3 months 2. Current or recent hospitalisation (less than 6 weeks) prior to screening period 3. Dysfunctional or infected vascular access 4. Intolerance to high-flux hemodialyser 5. Intolerance to multi-vitamin supplement 6. Severe co-morbidities limiting expected life expectance to less than 6 months 7. History of severe congestive heart failure (New York Heart Association [NYHA] class III and IV) 8. Uncontrolled hypertension (HTN) (systolic blood pressure [BP] over 200 or diastolic over 110) during the two week screening period 9. Significant and instable hypotension (systolic BP less than 90 or greater than 2 hypotension episodes/dialysis session for more than 3 sessions) during the two week screening period 10. Use of midodrine 11. Hepatite B, C or human immunodeficiency virus (HIV) positive serologies 12. Presence of pure red cell aplasia (PRCA) 13. Pregnancy or lactating 14. Current participation (or for less than 3 months) in another intervention trial 15. Presence of psychiatric, dependance or any other health problems that may compromise the hability of the subject to signed the informed consent form and/or affect compliance to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean % reduction of B2-microglobuline plasma concentration during a mid-week session 2. Substitution fluid analysis (microbiology: culture and endotoxins and biochemical content) | — |
Secondary
| Measure | Time frame |
|---|---|
| A variety of exploratory outcomes: biochemical [for example Kt/V, total urea, creatinine of B2-microglobulin clearance, pre-post study change in b2-microglobulin concentrations, CRP, etc], dialysis tolerance, quality of life, nutritional parameters, etc). | — |
Countries
Canada
Outcome results
None listed