Hypotension Clinical Trial
Official title:
Randomized Controlled Study on the Effect of the Hemodiafiltration Plasma Sodium Biofeedback System on Cardiovascular Stability in Hemodialysis Patients
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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