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HFR A-equilibrium on Cardiovascular Stability

NCT01414842 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-08-29

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Automated 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.

DEVICE

Standard sodium dialysate

Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER

  • Centre Pasteur Vallery Radot

    collaborator UNKNOWN

  • Azienda Ospedaliera di Lecco

    lead OTHER

Principal Investigators

  • Francesco Locatelli, Prof. · Azienda Ospedaliera di Lecco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-10-31
Completion
2008-12-31

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01414842 on ClinicalTrials.gov