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Automatic Adaptive System Dialysis (AASD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01241994
First Posted: November 16, 2010
Last Update Posted: November 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St. Orsola Hospital
  Purpose
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).

Condition Intervention
Dialysis Intolerance Other: AASD dialysis technique

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

Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:
  • number of intradialytic hypotensive events

Secondary Outcome Measures:
  • percentage of dysequilibrium symptoms

Arms Assigned Interventions
No Intervention: basal hemodialysis
Active Comparator: AASD Other: AASD dialysis technique

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241994


Locations
Italy
policlinico S. Orsola
Bologna, Italy, 40100
Sponsors and Collaborators
St. Orsola Hospital