Automatic Adaptive System Dialysis (AASD)

N/ACompletedNCT01241994

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Overview

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).

Study Type

INTERVENTIONAL

Conditions

Dialysis Intolerance

Interventions

AASD dialysis techniqueOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

policlinico S. Orsola

Bologna, Italy

Outcomes

Primary Outcomes

number of intradialytic hypotensive events

Secondary Outcomes

percentage of dysequilibrium symptoms

Data from ClinicalTrials.gov

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