Clinical trial NCT01414842: HFR A-equilibrium on Cardiovascular Stability
Official title: Randomized Controlled Study on the Effect of the Hemodiafiltration Plasma Sodium Biofeedback System on Cardiovascular Stability in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension
Lead sponsor: Azienda Ospedaliera di Lecco
Sponsor class: OTHER
Collaborators: name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Centre Pasteur Vallery Radot
First posted: 2011-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aim of the present randomized controlled multinational trial is the comparison of a novel biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy, with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic overall and cardiovascular stability.

Detailed description: Online hemodiafiltration (OL-HDF) has been recently associated with better patient survival in comparison with standard hemodialysis in some large observational studies (Canaud et al, KI, 2006; Vilar et al, CJASN , 2009) supporting the hypothesis that convection can improve patients outcomes. Moreover, it has been demonstrated in randomized controlled trials (Locatelli et al, Journal American Society of Nephrology, 2010) that OL-HDF significantly reduced the frequency of intradialytic hypotension. Nonetheless, the associated comorbidities and ageing of dialysis population require further devices able to improve treatment tolerance. Among these tools, the sodium profiling and biofeedback system seem to be promising to accomplish this task. But the correct intradialytic sodium balance is still far away today to be easily achieved. The use of an automated adaptive system dialysis to the sodium profiling has been investigated in a feasibility trial (Colì et al International Journal Artificial Organs, 2003). They also investigated the impact of such a device on treatment tolerance.

The aim of this randomized multinational multicenter controlled trial is to evaluate the impact of sodium profiling applied to a endogenous hemodiafiltration technique on the intradialytic cardiovascular stability in comparison to standard no profiled endogenous hemodiafiltration.

Eligibility criteria: Inclusion Criteria:

* Patients with more than 30% of dialysis complicated by hypotension
* age between 18 and 85 yers
* time on dialysis greater than 6 months
* residual creatinine clearance less than 2 ml/min/1.73 m2
* native fistula or central venous catheter with blood flow rate greater than 250 ml/min

Exclusion Criteria:

* Life expectancy less than 1 year
* solid active neoplasm
* pregnancy
* major event in the previous 3 months (ictus, myocardial infarction, cachexia)

Primary outcomes:
measure: Number of dialysis complicated by at least one hypotension
timeFrame: six months
Secondary outcomes:
measure: Blood Pressure Intradialytic symptoms
timeFrame: six months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Hospital Erasme
city: Paris
country: France
facility: Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat
city: Vannes
country: France
facility: Civil Hospital Bretagne Atlantique
city: Rostock
country: Germany
facility: Clinic of Internal Medicine
city: Ancona
country: Italy
facility: Nephrology and Dialysis Unit Ospedali Riuniti
city: Bologna
country: Italy
facility: UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi
city: Ciriè
country: Italy
facility: Civil Hospital
city: Foggia
country: Italy
facility: PO Lastaria
city: Novara
country: Italy
facility: Hospital Maggiore della Carità
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco
city: Barcellona
country: Spain
facility: Hospital Val d'Hebron
Study officials:
affiliation: Azienda Ospedaliera di Lecco
name: Francesco Locatelli, Prof.
role: STUDY_CHAIR
References: