Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT00993733
Status:
WITHDRAWN
Last Update Posted:
2016-03-23
First Post:
2009-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study has never been started', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2009-10-09', 'studyFirstSubmitQcDate': '2009-10-09', 'lastUpdatePostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time of nursing work required to realised a CVVHDF as a conventional and on line methods modality of supply compared to a method on-line', 'timeFrame': 'Day 1', 'description': 'The end of the study for the patient corresponds to the end of CVVHDF conventional and on line.'}], 'secondaryOutcomes': [{'measure': 'costs of CVVHDF performed using a conventional and on-line methods', 'timeFrame': 'Day 1', 'description': 'The end of the study for the patient corresponds to the end of CVVHDF conventional and on line.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemodiafiltration', 'cost', 'dialysis solution', 'acute renal failure', 'intensive care unit'], 'conditions': ['Acute Renal Failure']}, 'descriptionModule': {'briefSummary': 'The prevalence of acute renal failure in intensive care is estimated at between 5 and 20% depending on diagnostic criteria retained. And half of patients require the use of hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis technique widely used in intensive care unit.\n\nThe CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane, a blood circuit, a dialysate circuit and a feedback circuit.\n\nThe implementation of a CVVHDF requires the use of large amounts of biological liquid essential to enable the purification of blood during its passage through the artificial kidney.\n\nThe objective of this study is to assess time nursing work and the costs of each method.', 'detailedDescription': 'The prevalence of acute renal failure in intensive care is estimated at between 5 and 20% depending on diagnostic criteria retained. And half of patients require the use of hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis technique widely used in intensive care unit.\n\nThe CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane, a blood circuit, a dialysate circuit and a feedback circuit.\n\nThe implementation of a CVVHDF requires the use of large amounts of biological liquid essential to enable the purification of blood during its passage through the artificial kidney. The biological fluid may be supplied to the generator of CVVHDF in 2 ways:\n\n* The conventional method, the most used: the generator operates with pockets containing dialysis fluid, these pockets to be changed regularly by nurses\n* The on-line method: the generator operates with a specific water system supplying the dialysis fluid available in every room of the unit The objective of this study is to assess time nursing work and the costs of each method.\n\nFor this, 15 patients will be included in this study. Each patient performs 12 hours of each method (conventional and online), whose order will be randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient affiliated with or beneficiary of a social security category\n* Patient with a renal failure requiring a CVVHDF for at least 2 cycles of 12 hours\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT00993733', 'briefTitle': 'Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care', 'orgStudyIdInfo': {'id': '1008019'}, 'secondaryIdInfos': [{'id': '2010-A00695-34', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CVVHDF on-line', 'description': 'CVVHDF using a central water treatment plant, providing dialysate directly to the patient. They will perform a continuous veno-venous haemodiafiltration.', 'interventionNames': ['Procedure: Continuous veno-venous haemodiafiltration']}, {'type': 'EXPERIMENTAL', 'label': 'classical CVVHDF', 'description': 'CVVHDF using a mobile generator with dialysate bags. They will perform a continuous veno-venous haemodiafiltration.', 'interventionNames': ['Procedure: Continuous veno-venous haemodiafiltration']}], 'interventions': [{'name': 'Continuous veno-venous haemodiafiltration', 'type': 'PROCEDURE', 'otherNames': ['Classical CVVHDF : dialusate generator Prismaflex (HOSPAL)', 'CVVHDF on-line : dialysate generator 5008 (Fresenius)'], 'description': 'Dialysis procedure administrated to the patients with acute renal failure', 'armGroupLabels': ['CVVHDF on-line', 'classical CVVHDF']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Manolie Mehdi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}