Automatic Adaptive System Dialysis (AASD)

Not Applicable

Completed

• Conditions: Dialysis Intolerance
• Interventions: Other: AASD dialysis technique

• Registration Number: NCT01241994
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AASD	AASD dialysis technique	-

Primary Outcome Measures

Name	Time	Method
number of intradialytic hypotensive events

Secondary Outcome Measures

Name	Time	Method
percentage of dysequilibrium symptoms

Trial Locations

Locations (1)

policlinico S. Orsola; 🇮🇹 Bologna, Italy