Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-28 @ 4:55 PM
Study NCT ID:
NCT07183592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the ICU - A Randomized Controlled Trial
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2830}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate (%) of patients with with a central venous catheter-related infectious complication', 'timeFrame': 'From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).', 'description': 'Infectious complications include:\n\n1. Catheter-related infections (CRI) defined as:\n\n * A positive catheter culture, with quantitative culture ≥10³ CFU/ml (Brun-Buisson technique) or, if not available, a semi-quantitative culture \\>15 CFU (Maki technique), and purulence at the catheter insertion site or tunnelitis.\n\n Or\n * A positive catheter culture, with quantitative culture ≥10³ CFU/ml (or semi-quantitative culture \\>15 CFU), and complete or partial regression of systemic signs of infection within 48 hours after catheter removal.\n2. Catheter-related bloodstream infections (bacteremia or fungemia) defined as:\n\n * The occurrence of bacteremia (or fungemia) within 48 hours before or after catheter removal (or suspected catheter-related infection if the catheter is not immediately removed), And\n * Either a positive culture with the same microorganism from the insertion site or catheter, with ≥10³ CFU/ml (Brun-Buisson technique) or, if not available, a semi-quantitative culture'}], 'secondaryOutcomes': [{'measure': 'Central line-associated bloodstream infection (CLABSI)', 'timeFrame': 'Day 90', 'description': 'Proportion of patients with central line-associated bloodstream infection'}, {'measure': 'Non-central line-associated bloodstream infection', 'timeFrame': 'Day 90', 'description': 'Proportion of patients with non-central line-associated bloodstream infection'}, {'measure': 'Catheters with catheter colonization', 'timeFrame': 'From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).', 'description': 'Proportion of catheters with catheter colonization'}, {'measure': 'Time to onset of central venous catheter-related infectious complication', 'timeFrame': 'Day 90', 'description': 'Length of time (in days) before the onset of central venous catheter-related infectious complications'}, {'measure': 'ICU length of stay', 'timeFrame': 'Day 90', 'description': 'Length of ICU stay'}, {'measure': 'All-cause ICU mortality', 'timeFrame': 'Day 90', 'description': 'Number of patients who die from any cause during their ICU stay'}, {'measure': 'Cumulative nursing time related to infusion set replacements', 'timeFrame': '1000 days', 'description': 'Total nursing time, measured in minutes, required to perform infusion set replacements, per 1000 catheter-days'}, {'measure': 'Cost of materials required for infusion set replacements', 'timeFrame': '1000 days', 'description': 'Cost (euros) of materials required for infusion set replacements, per 1000 cathéter days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intensive Care (ICU)', 'Central Venous Catheter Related Infections', 'Critical Care Nursing', 'Catheter-associated Bloodstream Infections (CLABSI)', 'Nursing Workload']}, 'descriptionModule': {'briefSummary': "In the intensive care unit, patients' care and secure drugs administration require a central venous catheter. These invasive devices can lead to complications, particularly infections. Most preventive recommendations focus on catheter insertion, line handling, and dressings. Few recommendations adress catheter dwell time, which is certainly the main source of infection. Part of the prevention strategy is the regular and systematic replacement of infusion sets , as they may become contaminated during use, mainly through the hands of healthcare professionals. Prolonged use increases the risk of infection. Infusion lines changes involve disconnecting the old sets, discarding infusion devices containing drug residues, and replacing them with new sterile devices.\n\nCurrent international guidelines recommend replacing these sets every 4 days, and the Center for Disease Control and Prevention recommends not exceeding 7 days. Replacing these devices requires the time of qualified nurses, numerous sterile medical devices, and medications. In addition to the intended effect on infection prevention, the procedure has impacts on workload and costs.\n\nThe objective of the study is to demonstrate that changing infusion set every 7 days does not increase the rate of central venous catheters related infections compared with changing infusion set every 4 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Adult patient\n* Any ICU patient with a central venous catheter (inserted by venipuncture) in place for less than 72 hours and with an expected dwell time of at least 7 days\n* Patient affiliated with or covered by a social security system\n* Patient who has given verbal consent or written consent from a third party or in the event that the patient is unable to give consent.\n\nExclusion Criteria\n\n* Patient with a documented bloodstream infection at the time of inclusion\n* Patient whose central venous catheter has been in place for more than 72 hours\n* Patient with suspected catheter-related infection\n* Patient whose study catheter was inserted using a guidewire exchange\n* Patient previously enrolled in the study during the same ICU stay\n* Patient whose condition, according to the clinician, does not allow safe placement of a central venous catheter, such as:\n\n * Allergy to catheter material\n * Confirmed deep vein thrombosis at the time of insertion\n * Inflammatory skin disorder at the insertion site\n* Patient admitted for extensive burns\n* Inadequate understanding of the French language\n* Pregnant, breastfeeding, or postpartum woman\n* Person deprived of liberty by judicial or administrative decision\n* Person receiving involuntary psychiatric care\n* Person under legal guardianship or other legal protection measure'}, 'identificationModule': {'nctId': 'NCT07183592', 'acronym': 'TANDOORI', 'briefTitle': 'Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the ICU - A Randomized Controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the Intensive Care Unit ICU', 'orgStudyIdInfo': {'id': '49RC24_0290'}, 'secondaryIdInfos': [{'id': '2025-A01509-40', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7-day infusion set replacement', 'description': 'Infusion sets connected to the central venous catheter will be replaced every 7 days.', 'interventionNames': ['Procedure: 7-day Infusion set replacement']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4-day infusion set replacement', 'description': 'Infusion sets connected to the central venous catheter will be replaced every 4 days.', 'interventionNames': ['Procedure: 4-day infusion set replacement']}], 'interventions': [{'name': '7-day Infusion set replacement', 'type': 'PROCEDURE', 'description': '7-day infusion set replacement (Experimental arm) In this group, the infusion sets (the tubes and connectors used to deliver medications through the central venous catheter) will be changed once a week, every 7 days. During each replacement, all sets will be disconnected and replaced with new sterile ones.', 'armGroupLabels': ['7-day infusion set replacement']}, {'name': '4-day infusion set replacement', 'type': 'PROCEDURE', 'description': '4-day infusion set replacement (Active comparator arm) In this group, the infusion sets will be changed every 4 days, which reflects the most common international recommendation. The procedure is the same: all sets connected to the central venous catheter will be replaced with new sterile ones. This strategy represents the current standard of care and will serve as the comparison for the 7-day approach.', 'armGroupLabels': ['4-day infusion set replacement']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BP350 97448', 'city': 'Saint-Pierre', 'state': 'La Réunion', 'country': 'France', 'contacts': [{'name': 'Nathalie Zemire', 'role': 'CONTACT', 'email': 'nathalie.zemire@chu-reunion.fr', 'phone': '+33262359000'}], 'facility': 'La Réunion University Hospital', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}, {'zip': '81000', 'city': 'Albi', 'country': 'France', 'contacts': [{'name': 'Simon Gayrard', 'role': 'CONTACT', 'email': 'simon.gayrard@ch-albi.fr', 'phone': '+33563480653'}], 'facility': 'Albi Hospital', 'geoPoint': {'lat': 43.9298, 'lon': 2.148}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Carole Haubertin', 'role': 'CONTACT', 'phone': '+332 41 35 40 82'}], 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '90015', 'city': 'Belfort', 'country': 'France', 'contacts': [{'name': 'Nahila Himer', 'role': 'CONTACT', 'email': 'Nahila.HIMER@hnfc.fr', 'phone': '+33384983573'}], 'facility': 'Belfort Hospital', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'zip': '18000', 'city': 'Bourges', 'country': 'France', 'contacts': [{'name': 'Anna Bourreau', 'role': 'CONTACT', 'email': 'anna.bourreau@ch-bourges.fr', 'phone': '+33248484848'}], 'facility': 'Bourges Hospital', 'geoPoint': {'lat': 47.08333, 'lon': 2.4}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'contacts': [{'name': 'Agathe Hamelin', 'role': 'CONTACT', 'email': 'hamelin-a@chu-caen.fr', 'phone': '+33231064711'}], 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Chartres', 'country': 'France', 'contacts': [{'name': 'Justine Clavelou', 'role': 'CONTACT', 'email': 'clavelou.justine@gmail.com', 'phone': '+332 37 30 30 30'}], 'facility': 'Chartres Hospital', 'geoPoint': {'lat': 48.44685, 'lon': 1.48925}}, {'zip': '49300', 'city': 'Cholet', 'country': 'France', 'contacts': [{'name': 'Charlotte Debarre', 'role': 'CONTACT', 'email': 'charlotte.debarre@ch-cholet.fr', 'phone': '+332414966398'}], 'facility': 'Cholet Hospital', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'zip': '92700', 'city': 'Colombes', 'country': 'France', 'contacts': [{'name': 'Blandine Dutrech', 'role': 'CONTACT', 'email': 'blandine.bourreau-gueriniere@aphp.fr', 'phone': '+33147606833'}], 'facility': 'Colombes Hospital', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '91106', 'city': 'Corbeil-Essonnes', 'country': 'France', 'contacts': [{'name': 'Justine Nunes', 'role': 'CONTACT', 'email': 'justine.nunes@chsf.fr', 'phone': '+33161695007'}], 'facility': 'Corbeil-Essonnes Hospital', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'contacts': [{'name': 'Marianne Le Joncour', 'role': 'CONTACT', 'email': 'marianne.lejoncour@aphp.fr', 'phone': '+331 49 81 24 36'}], 'facility': 'AP-HP - Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Jean-Pierre Quenot', 'role': 'CONTACT', 'email': 'jean-pierre.quenot@chu-dijon.fr', 'phone': '+333 85 27 54 10'}], 'facility': 'Dijon University Hospital', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Garches', 'country': 'France', 'contacts': [{'name': 'Segolene Jourdier', 'role': 'CONTACT', 'email': 'segolene.jourdier@aphp.fr', 'phone': '+33147107778'}], 'facility': 'Garches Hospital', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '43000', 'city': 'Le Puy-en-Velay', 'country': 'France', 'contacts': [{'name': 'Isabelle Roure', 'role': 'CONTACT', 'email': 'isabelle.roure@ch-lepuy.fr', 'phone': '+33471043537'}], 'facility': 'Le Puy en Velay Hospital', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}, {'zip': '71000', 'city': 'Mâcon', 'country': 'France', 'contacts': [{'name': 'Marine Alissant', 'role': 'CONTACT', 'email': 'maalissant@ch-macon.fr', 'phone': '+33380293685'}], 'facility': 'Macon Hospital', 'geoPoint': {'lat': 46.31407, 'lon': 4.82823}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'contacts': [{'name': 'Jerome Dauvergne', 'role': 'CONTACT', 'email': 'jerome.dauvergne@chu-nantes.fr', 'phone': '+332 40 16 52 84'}], 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'contacts': [{'name': 'Amandine Thiery', 'role': 'CONTACT', 'email': 'amandine.thiery@chu-orleans.fr', 'phone': '+332 38 51 44 46'}], 'facility': 'Orleans University Hospital', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Guillaume Voiriot', 'role': 'CONTACT', 'email': 'guillaume.voiriot@aphp.fr', 'phone': '+331 56 01 55 98'}], 'facility': 'AP-HP - Tenon Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'contacts': [{'name': 'Djeneba Camara', 'role': 'CONTACT', 'email': 'djeneba.camara@ght-novo.fr', 'phone': '+33130755059'}], 'facility': 'Pontoise Hospital', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Julien Demiselle', 'role': 'CONTACT', 'email': 'julien.demiselle@chru-strasbourg.fr', 'phone': '+33369551079'}], 'facility': 'Strasbourg University Hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Carole Haubertin', 'role': 'CONTACT', 'email': 'Carole.Haubertin@chu-angers.fr', 'phone': '+332 41 35 40 82'}, {'name': 'Aurélie Hautefort', 'role': 'CONTACT', 'email': 'aurelie.hautefort@chu-angers.fr', 'phone': '+332 41 35 58 99'}], 'overallOfficials': [{'name': 'Carole Haubertin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}