Automatic Adaptive System Dialysis (AASD)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Dialysis Intolerance

Treatments: Other: AASD dialysis technique

Study type: Interventional

Funder types: Other

Identifiers

NCT01241994

106/2004/U/Oss

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

0 participants in 2 patient groups

basal hemodialysis

No Intervention group

AASD

Active Comparator group

Treatment:

Other: AASD dialysis technique