A European study on acetate free biofiltration versus bicarbonate dialysis (quality control)

Completed

• Conditions: Renal failure requiring haemodialysis; Urological and Genital Diseases; Renal failure

• Registration Number: ISRCTN37257308
• Lead Sponsor: Hospal S.p.A. (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.