Automatic Adaptive System Dialysis (AASD)

This study has been completed.
Sponsor:
Information provided by:
St. Orsola Hospital
ClinicalTrials.gov Identifier:
NCT01241994
First received: November 15, 2010
Last updated: NA
Last verified: January 2004
History: No changes posted

November 15, 2010
November 15, 2010
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number of intradialytic hypotensive events
Same as current
No Changes Posted
percentage of dysequilibrium symptoms
Same as current
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Automatic Adaptive System Dialysis (AASD)
Automatic Adaptive System Dialysis (AASD) for Dialysis Related Hypotension and Intolerance: a Prospective Long-term Multicenter Study

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).

Not Provided
Interventional
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Dialysis Intolerance
Other: AASD dialysis technique
  • No Intervention: basal hemodialysis
  • Active Comparator: AASD
    Intervention: Other: AASD dialysis technique

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01241994
106/2004/U/Oss
No
Not Provided
St. Orsola Hospital
Not Provided
Not Provided
St. Orsola Hospital
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP