Automatic Adaptive System Dialysis (AASD)

This study has been completed.

Sponsor:

Information provided by:

St. Orsola Hospital

ClinicalTrials.gov Identifier:

NCT01241994

First received: November 15, 2010

Last updated: NA

Last verified: January 2004

History: No changes posted

Tracking Information
First Received Date ^ICMJE	November 15, 2010
Last Updated Date	November 15, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: November 15, 2010)	number of intradialytic hypotensive events
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: November 15, 2010)	percentage of dysequilibrium symptoms
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Automatic Adaptive System Dialysis (AASD)
Official Title ^ICMJE	Automatic Adaptive System Dialysis (AASD) for Dialysis Related Hypotension and Intolerance: a Prospective Long-term Multicenter Study
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Dialysis Intolerance
Intervention ^ICMJE	Other: AASD dialysis technique
Study Arm (s)	No Intervention: basal hemodialysis Active Comparator: AASD Intervention: Other: AASD dialysis technique
Publications *	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. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01241994
Other Study ID Numbers ^ICMJE	106/2004/U/Oss
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	St. Orsola Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	St. Orsola Hospital
Verification Date	January 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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