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
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
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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.