- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01241994
Automatic Adaptive System Dialysis (AASD)
March 17, 2021 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Automatic Adaptive System Dialysis (AASD) for Dialysis Related Hypotension and Intolerance: a Prospective Long-term Multicenter Study
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bologna, Italy, 40100
- Policlinico S. Orsola
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: basal hemodialysis
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Active Comparator: AASD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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number of intradialytic hypotensive events
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Secondary Outcome Measures
Outcome Measure |
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percentage of dysequilibrium symptoms
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Coli 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.
- Ursino M, Coli 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 15, 2010
First Submitted That Met QC Criteria
November 15, 2010
First Posted (Estimate)
November 16, 2010
Study Record Updates
Last Update Posted (Actual)
March 18, 2021
Last Update Submitted That Met QC Criteria
March 17, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 106/2004/U/Oss
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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