24-hour electrocardiogram profiles during acetate-free biofiltration with constant and potassium-profiled dialysate
| ISRCTN | ISRCTN20002762 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20002762 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/06/2006
- Registration date
- 14/07/2006
- Last edited
- 08/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Antonio Santoro
Scientific
Scientific
Azienda Ospedaliera Policlinico Sant'Orsola-Malpighi
Divisione di Nefrologia e Dialisi
Via Palagi 9
Bologna
40128
Italy
Study information
| Study design | Multicenter, randomised, crossover, single-blind scheme with two arms. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 24/02/2003 |
| Completion date | 22/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 patients (Italian and French dialysis centres) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/02/2003 |
| Date of final enrolment | 22/02/2005 |
Locations
Countries of recruitment
- France
- Italy
Study participating centre
Azienda Ospedaliera Policlinico Sant'Orsola-Malpighi
Bologna
40128
Italy
40128
Italy
Sponsor information
Hospal S.p.A. (Italy)
Industry
Industry
Via Ferrarese 219/9
Bologna
40128
Italy
"ROR" |
https://ror.org/02kf9ya90 |
|---|
Funders
Funder type
Industry
Hospal S.p.A. (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/12/2005 | Yes | No |
