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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN37257308
• Date of registration: 03/07/2006
• Prospective Registration: No
• Primary sponsor: Hospal S.p.A. (Italy)
• Public title: A European study on acetate free biofiltration versus bicarbonate dialysis (quality control)
• Date of first enrolment: 01/10/1997
• Target sample size: 400
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN37257308
• Study type: Interventional
• Study design: Prospective, randomised, long-term study (Treatment)

Countries of recruitment

Czech Republic, France, Germany, Italy, Spain

Contacts

• Name: Antonio Santoro

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Renal failure requiring haemodialysis
Urological and Genital Diseases
Renal failure

Intervention(s)

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 bicarbonate solution with a concentration to be chosen between 145 mEq/l and 167 mEq/l in such a quantity as to guarantee a post-dialysis bicarbonatemia between 27 and 30 mEq/l.

Both AFB and bicarbonate dialysis will be conducted using haemodialysers with controlled ultrafiltration rate.

For the bicarbonate dialysis we require the use of a biocompatible membrane, such as AN69, or a low-flux membrane such as low-flux synthetic or cellulose-modified membrane (ultrafiltration rate less than 20).

The inclusion of AN69 in bicarbonate dialysis will allow us to separate the role of the membrane from that of the dialysis methodology.

Ratio of the pre- and post-dialysis urea concentrations (KT/V) = 1,2 and, at any rate, the same for the two dialysis methods within the same Centre. The KT/V is calculated with Daugirdas? second generation formula.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Hospal S.p.A. (Italy)