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OpenTrials
Completed

NCT Number: NCT01241994

Automatic Adaptive System Dialysis (AASD)

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. The aim of dialysate sodium and ultrafiltration rate profile is to obtain the higher stabilization of intradialytic extra cellular compartment, in consideration of end session targets: body weight and final patient's natremia. In this multicenter prospective controlled randomized trial the primary end-point is the clinical efficiency validation of AASD on intradialytic hypotension but also on thirst, cramps, headache, nausea, vomiting, hypotensive events observed in basal treatment (HD or HDF).

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Key information

Conditions

Dialysis Intolerance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

policlinico S. Orsola

Bologna, 40100, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

AASD dialysis technique

Other

Primary outcomes

  1. number of intradialytic hypotensive events

Secondary outcomes

  1. percentage of dysequilibrium symptoms

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Automatic Adaptive System Dialysis (AASD) for Dialysis Related Hypotension and Intolerance: a Prospective Long-term Multicenter Study

Important dates

First posted
Nov 16, 2010
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.