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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
  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

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241994

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

Publications:

ClinicalTrials.gov Identifier: NCT01241994     History of Changes
Other Study ID Numbers: 106/2004/U/Oss
Study First Received: November 15, 2010
Last Updated: November 15, 2010
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

ClinicalTrials.gov processed this record on May 22, 2013