Renal failure requiring haemodialysis Urological and Genital Diseases Renal failure
Conditions
Interventions
AFB and bicarbonate dialysis will be carried out in line with the protocols normally used in dialysis centres.
AFB will be conducted using haemodialysers with AN69 membranes and infusing a sodium bic
Sponsors
Hospal S.p.A. (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All new patients (who started haemodialysis up to ten months prior to the start of the protocol) defined as ?critical? will be included in the study after an adequate information about the aims of the study. Critical patients are defined as such if they present at least one of the following conditions: 1. Diabetes 2. Age equal or over 60 years 3. Cardiovascular instability (defined as a frequency of hypotensive episodes in more than 20% of dialysis sessions, or independently of frequency, if hypotension is accompanied by angina or major arrhythmia's)
Exclusion criteria
Exclusion criteria: 1. Age greater than 78 years 2. Active neoplasia 3. Severe cardiopathies (New York Heart Association [NYHA] Class III & Class IV) 4. Decompensating cirrhosis 5. Poor vascular access function (pump flow (Qb) less than 200 ml/m or need for single needle system) 6. Previous continuous ambulatory peritoneal dialysis (CAPD) treatment or kidney transplant 7. On waiting list for kidney transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this multicentric trial is to verify, in a large group of patients, the long-term outcomes in term of mortality rate between AFB and bicarbonate dialysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary aims are to verify the clinical effects of AFB on intra and inter-dialytic symptoms, metabolic and nutritional indexes, morbidity, patients? well-being and quality of life. | — |
Countries
Czech Republic, France, Germany, Italy, Spain
Outcome results
None listed