Status:

COMPLETED

Automatic Adaptive System Dialysis (AASD)

Lead Sponsor:

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Conditions:

Dialysis Intolerance

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

AASD is a new dialysis technique based on the use of a mathematical model of intradialytic solutes and fluid kinetic, for the automatic elaboration of dialysate sodium and ultrafiltration rate profile...

Eligibility Criteria

Inclusion

  • Patients in HD/HDF (bicarbonate dialysis/hemodiafiltration) for at least 6 months
  • aged more than 18 years
  • on chronic thrice-weekly HD
  • symptomatic hypotension during at least 30% of dialysis sessions on basal treatment in the last month before admission or/and 1 hypotension /week
  • disequilibrium symptoms (cramps, headache, nausea, vomiting, hypotensive events) in at least 30% of dialysis sessions on basal treatment
  • dialysis session time: 4 hours (as much as possible)
  • Signed inform consent form
  • Patients having no vascular access related problems (bi-ponction, blood flow rate 300ml/min)

Exclusion

  • Patients in a pregnant state
  • Patients whose life expectancy is less than study period
  • Patients with progressive acute pathology (neoplasia…)
  • Patients included in an other protocol
  • Psychiatric patients or patients unable to consent or unable to follow the study

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01241994

Last Update

March 18 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

policlinico S. Orsola

Bologna, Italy, 40100

Automatic Adaptive System Dialysis (AASD) | DecenTrialz