Status:

COMPLETED

HFR A-equilibrium on Cardiovascular Stability

Lead Sponsor:

Azienda Ospedaliera di Lecco

Collaborating Sponsors:

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Centre Pasteur Vallery Radot

Conditions:

Hypotension

Eligibility:

All Genders

18-85 years

Phase:

PHASE4

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 (n...

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 ...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

April 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT01414842

Start Date

April 1 2007

End Date

December 1 2008

Last Update

August 29 2011

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Hospital Erasme

Brussels, Belgium

2

Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat

Paris, France

3

Civil Hospital Bretagne Atlantique

Vannes, France

4

Clinic of Internal Medicine

Rostock, Germany