Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 4:59 AM
Study NCT ID:
NCT01241994
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2010-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automatic Adaptive System Dialysis (AASD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2010-11-15', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of intradialytic hypotensive events'}], 'secondaryOutcomes': [{'measure': 'percentage of dysequilibrium symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dialysis Intolerance']}, 'referencesModule': {'references': [{'pmid': '9509454', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '10212044', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:Patients in HD/HDF (bicarbonate dialysis/hemodiafiltration) for at least 6 months\n\n* aged more than 18 years\n* on chronic thrice-weekly HD\n* symptomatic hypotension during at least 30% of dialysis sessions on basal treatment in the last month before admission or/and 1 hypotension /week\n* disequilibrium symptoms (cramps, headache, nausea, vomiting, hypotensive events) in at least 30% of dialysis sessions on basal treatment\n* dialysis session time: 4 hours (as much as possible)\n* Signed inform consent form\n* Patients having no vascular access related problems (bi-ponction, blood flow rate 300ml/min)\n\nExclusion Criteria: Patients in a pregnant state\n\n* Patients whose life expectancy is less than study period\n* Patients with progressive acute pathology (neoplasia…)\n* Patients included in an other protocol\n* Psychiatric patients or patients unable to consent or unable to follow the study'}, 'identificationModule': {'nctId': 'NCT01241994', 'briefTitle': 'Automatic Adaptive System Dialysis (AASD)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Automatic Adaptive System Dialysis (AASD) for Dialysis Related Hypotension and Intolerance: a Prospective Long-term Multicenter Study', 'orgStudyIdInfo': {'id': '106/2004/U/Oss'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'basal hemodialysis'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AASD', 'interventionNames': ['Other: AASD dialysis technique']}], 'interventions': [{'name': 'AASD dialysis technique', 'type': 'OTHER', 'armGroupLabels': ['AASD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100', 'city': 'Bologna', 'country': 'Italy', 'facility': 'policlinico S. Orsola', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}}}}