Condition category
Urological and Genital Diseases
Date applied
14/06/2006
Date assigned
03/07/2006
Last edited
08/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Antonio Santoro

ORCID ID

Contact details

Azienda Ospedaliera Policlinico Sant'Orsola Malpighi
Divisione di Nefrologia e Dialisi
Via Palagi
9
Bologna
40138
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

It is a known fact that quality of life is poor in a large proportion of dialysis patients and that life expectancy is four to six times shorter than in non-dialysed subjects. Much effort is thus required to improve clinical results in terms of cost-effectiveness, reducing complications, and improving the quality of life being offered. Adequate dialysis treatments and biocompatibility may not only affect the acute intradialysis events, but may also have an impact on interdialysis morbidity and possible long-term complications.

Acetate free biofiltration (AFB) is a dialysis treatment based on a buffer-free dialysate and a bicarbonate infusion in the post-dilution mode. AFB has been used for both children and adults, favourably affecting the acid-base balance and the nutritional indexes.

Furthermore, a lot of studies have shown that AFB can improve cardiovascular stability during ultrafiltration and reduce dialysis symptoms. Nevertheless, all the studies performed so far have been short-term, since the monitoring time has been one year or less, and so the long-term effects of AFB on the clinical outcome remains to be established.

On theoretical grounds, a dialytic procedure capable of improving small and medium size solute clearance, vascular tolerance, acid-base equilibrium correction, and membrane-associated reactions, seems to possess the characteristics to improve the long-term clinical results by slowing down or preventing the onset of complications.

Ethics approval

Ethics committee approval given by the ethical committee of the Hospital Sant' Orsola-Malpighi on the 25th January 1998 (ref: 139 SC).

Study design

Prospective, randomised, long-term study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Renal failure requiring haemodialysis

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Sodium bicarbonate

Primary outcome measures

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

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.

Overall trial start date

01/10/1997

Overall trial end date

07/01/2000

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

No. of patients: more or equal to 400

Participant 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

Recruitment start date

01/10/1997

Recruitment end date

07/01/2000

Locations

Countries of recruitment

Czech Republic, France, Germany, Italy, Spain

Trial participating centre

Azienda Ospedaliera Policlinico Sant'Orsola Malpighi
Bologna
40138
Italy

Sponsor information

Organisation

Hospal S.p.A. (Italy)

Sponsor details

Via Ferrarese
219/9
Bologna
40128
Italy

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Hospal S.p.A. (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes