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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1
policlinico S. Orsola
Bologna, Italy, 40100