Automatic Adaptive System Dialysis (AASD)

Dialysis Intolerance Clinical Trial

Official title:

Automatic Adaptive System Dialysis (AASD) for Dialysis Related Hypotension and Intolerance: a Prospective Long-term Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241994
• Other study ID #: 106/2004/U/Oss
• Status: Completed
• Phase: N/A

Study information

• Verified date: March 2021
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis Intolerance

Intervention

Other:
• AASD dialysis technique

Locations

Country	Name	City	State
Italy	policlinico S. Orsola	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Colì L, Ursino M, Dalmastri V, Volpe F, La Manna G, Avanzolini G, Stefoni S, Bonomini V. A simple mathematical model applied to selection of the sodium profile during profiled haemodialysis. Nephrol Dial Transplant. 1998 Feb;13(2):404-16. — View Citation

Ursino M, Colì L, Brighenti C, De Pascalis A, Chiari L, Dalmastri V, La Manna G, Mosconi G, Avanzolini G, Stefoni S. Mathematical modeling of solute kinetics and body fluid changes during profiled hemodialysis. Int J Artif Organs. 1999 Feb;22(2):94-107. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of intradialytic hypotensive events
Secondary	percentage of dysequilibrium symptoms