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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01241994
Enrollment
Unknown
Registered
2010-11-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis Intolerance

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. 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).

Interventions

OTHERAASD dialysis technique

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
number of intradialytic hypotensive events—

Secondary

MeasureTime frame
percentage of dysequilibrium symptoms—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026