Hypotension
Conditions
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.
Interventions
DEVICEAutomated sodium profiling in endogenous hemodiafiltration
Automated sodium profiling during endogenous reinfusion hemodiafiltration technique. The device processes the dialysate sodium and ultrafiltration rate during dialysis to achieve a preset sodium target at the end of the treatment. Sodium dialysate and maximal ultrafiltration rate are constraint within safety limits during dialysis.
DEVICEStandard sodium dialysate
Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Centre Pasteur Vallery Radot
Azienda Ospedaliera di Lecco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of dialysis complicated by at least one hypotension | six months | Hypotension definition: If predialysis systolic blood pressure greater than100 mmHg then a value during dialysis below 90 mmHg or any systolic blood pressure reduction greater than 25 mmHg in presence of symptoms or If predialysis systolic blood pressure less than 90 mmHg a reduction of at least 10% accompanied by symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Intradialytic symptoms | six months | Systolic, diastolic blood pressures (SBP, DBP) and heart rate (HR) measured at the beginning of each treatment and every 30 minutes till the end of dialysis; intradialytic symptoms (nausea, vomiting, hypotension, headache, cramps) and related clinical interventions. |
Countries
Belgium, France, Germany, Italy, Spain
Outcome results
None listed