Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-03-01 @ 10:09 AM
Study NCT ID:
NCT01898234
Status:
COMPLETED
Last Update Posted:
2013-07-12
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dialysis Membranes and Hemodynamic Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2013-07-02', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis', 'timeFrame': '4 weeks'}, {'measure': 'comparative evaluation of subjective tolerance across the various membranes', 'timeFrame': '4 weeks', 'description': 'As to the assessment of subjective tolerance, we decided to administer the questionnaire designed by Cruz et al. \\[Cruz DN, Mahnensmith RL, Brickel HM, Perazella MA. Midodrine and cool dialysate are effective therapies for symptomatic intradialytic hypotension. Am. J. Kidney Dis. 1999 Mag;33(5):920-926\\] then modified by Teruel et al. \\[Teruel JL, Martins J, Merino JL, Fernández Lucas M, Rivera M, Marcén R, et al. Temperature of the dialysis bath and hemodialysis tolerance. Nefrología: PublicaciónOficial De La Sociedad Española Nefrologia. 2006;26(4):461-468\\] and to integrate it with a 1 to 10 numerical scale to assess patient well-being'}, {'measure': 'comparative evaluation of Kt/V and of beta-2 microglobulin removal', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg)', 'timeFrame': '4 weeks'}]}, 'conditionsModule': {'keywords': ['Hemodynamics', 'intradialytic hypotension', 'subjective tolerance', 'dialysis membranes', 'high flux', 'low flux', 'hemodialysis'], 'conditions': ['Dialysis Membranes and Hemodynamic Tolerance']}, 'descriptionModule': {'briefSummary': 'Background:\n\nHigh- and low-flux dialysis membranes made of different materials may correlate with various hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and incidence of hypotensive episodes by comparing some of the most commonly used high- and low-flux dialyzers.\n\nMethodology:\n\nThe study was designed as an open label, randomized, cross-over investigation, including 25 patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other. The hemodynamic profile was assessed with a non-invasive technique and patients were asked to provide tolerance feedback through a questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 and older\n* ability to understand the information presented and sign the informed consent\n* chronic hemodialysis for at least 8 weeks\n* stable dialysis prescriptions and modality in the 2 weeks prior to protocol implementation\n\nExclusion Criteria:\n\n* mental illness;\n* inability to understand the information presented and sign the informed consent;\n* acute disease requiring hospitalization at the time of patient enrolment\n* pregnancy and breast feeding'}, 'identificationModule': {'nctId': 'NCT01898234', 'briefTitle': 'Dialysis Membranes and Hemodynamic Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Regionale di Locarno'}, 'officialTitle': 'Assessment of Subjective and Hemodynamic Tolerance of Different High- and Low-flux Dialysis Membranes in Patients Undergoing Chronic Intermittent Hemodialysis: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '012012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Revaclear', 'interventionNames': ['Device: Revaclear']}, {'type': 'EXPERIMENTAL', 'label': 'Helixone high flux', 'interventionNames': ['Device: Helixone high flux']}, {'type': 'EXPERIMENTAL', 'label': 'Xevonta', 'interventionNames': ['Device: Xevonta']}, {'type': 'EXPERIMENTAL', 'label': 'Helixone low flux', 'interventionNames': ['Device: Helixone low flux']}], 'interventions': [{'name': 'Revaclear', 'type': 'DEVICE', 'otherNames': ['-Revaclear, Gambro 1.8 m2'], 'description': 'Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other', 'armGroupLabels': ['Revaclear']}, {'name': 'Helixone high flux', 'type': 'DEVICE', 'otherNames': ['Helixone high flux, Fresenius 1.8 m2'], 'description': 'Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other', 'armGroupLabels': ['Helixone high flux']}, {'name': 'Xevonta', 'type': 'DEVICE', 'otherNames': ['Xevonta, BBraun 1.8 m2'], 'description': 'Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other', 'armGroupLabels': ['Xevonta']}, {'name': 'Helixone low flux', 'type': 'DEVICE', 'otherNames': ['Helixone low flux, Fresenius 1.8 m2'], 'description': 'Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other', 'armGroupLabels': ['Helixone low flux']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6928', 'city': 'Locarno', 'state': 'Canton Ticino', 'country': 'Switzerland', 'facility': 'Ospedale Regionale di Locarno', 'geoPoint': {'lat': 46.17086, 'lon': 8.79953}}], 'overallOfficials': [{'name': 'Luca Gabutti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Regionale Locarno'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Regionale di Locarno', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof, Head of Department of Internal Medicine', 'investigatorFullName': 'Luca Gabutti, MD', 'investigatorAffiliation': 'Ospedale Regionale di Locarno'}}}}