Condition category
Circulatory System
Date applied
16/06/2006
Date assigned
14/07/2006
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
40128
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The aim of the study is to evaluate the efficacy of acetate-free biofiltration (AFB) potassium-profiled dialysis in the reduction of the number of cardiac arrhythmias during treatment, compared to constant potassium AFB.

One of the most important electrolyte disorders of uremia is the increase in serum potassium levels. A clinical consequence of hyperkalaemia is hyperpolarisation block of neuromuscular cells, which starts with asthaenia, muscular pain and constipation. The most worrying clinical outcome is at cardiac level which can induce severe hypokinetic arrhythmias up to total atrio-ventricular block bundle. Severe hyperkalaemia leads to a potassium transfer, mediated by sodium/potassium adenosine triphosphatase (Na/K-ATP-ase) pump, towards the intracellular space, thus increasing the concentration at this site. The task of dialysis treatment is to remove the extra amount of potassium in the interdialytic period due to the exogenous intake induced by vegetables, fruits, and their juices. The amount of potassium removed by dialysis is related to the concentration gradient between the serum potassium level and the potassium content of the dialysis bath. Very low concentration in the bath can remove large amounts of potassium from the body but against that of an altered concentration gradient between intra- and extra-cellular space with the appearance of electrical instability of cellular membrane, in particular, in pacemaker heart cells. Hyperkinetic arrhythmias have been seen which can prove to be harmful for the cardiac function. This phenomenon is even more evident in the presence of cardiac co-morbid conditions such as dilated hypertrophic cardiomyopathy.

The need to join adequate potassium removal with the risk of cardiac failure suggests use of sequential removal of potassium during dialysis.

The acetate-free biofiltration potassium profiled (AFBK) is a dialytic therapy which has such a safe feature.

Ethics approval

The study received appropriate ethics committee approval on 19/09/2002 by the Ethical Committee of Policlinico Sant' Orsola-Malpighi, (Comitato Etico del Policlinico Sant'Orsola-Malpighi), reference number: 1264/2002

Study design

Multicenter, randomised, crossover, single-blind scheme with two arms.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cardiac arrhythmia

Intervention

Dialysis with AFB potassium-profiled (AFBK) dialysis versus constant constant AFB.
In both AFB and AFBK, AN69ST haemofilter (same size as used run in period) will be used. Blood and dialysate flow rate will be the same as well as the infusion flow rate. The bath preparation will be the same in both treatments, but not the potassium level. Bath conductivity must be set to obtain the same sodium bath content as the previous bicarbonate dialysis treatment. During the treatment, any additional intake of potassium must be avoided.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Aim of the study is to evaluate the efficacy of AFB potassium-profiled dialysis in the reduction of the number of cardiac arrhythmias during the treatment, compared to constant potassium AFB.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

24/02/2003

Overall trial end date

22/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. End stage renal disease (ESRD) patients
2. Duration of renal replacement therapy (RRT) for at least the last six months
3. Three times a week dialysis schedule
4. Patients who, at the time of admission to the study, are being treated with bicarbonate dialysis
5. Age greater than 18 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24 patients (Italian and French dialysis centres)

Participant exclusion criteria

1. Patients older than 80 years
2. Patients on antiarrhythmogenic treatment or antihypertensive treatment, which have a declared effect on cardiac rhythm
3. Patients receiving pacemaker or cardiac stimulator
4. Patients on variable digitalis dosage
5. Patients in hypokalemia

Recruitment start date

24/02/2003

Recruitment end date

22/02/2005

Locations

Countries of recruitment

France, Italy

Trial participating centre

Azienda Ospedaliera Policlinico Sant'Orsola-Malpighi
Bologna
40128
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

Results in http://www.ncbi.nlm.nih.gov/pubmed/15876853

Publication citations

  1. Results

    Santoro A, Mancini E, Gaggi R, Cavalcanti S, Severi S, Cagnoli L, Badiali F, Perrone B, London G, Fessy H, Mercadal L, Grandi F, Electrophysiological response to dialysis: the role of dialysate potassium content and profiling., Contrib Nephrol, 2005, 149, 295-305, doi: 10.1159/000085691.

Additional files

Editorial Notes