Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2026-03-05 @ 6:40 PM
Study NCT ID:
NCT01794767
Status:
SUSPENDED
Last Update Posted:
2015-10-29
First Post:
2013-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010689', 'term': 'Phlebitis'}, {'id': 'D005119', 'term': 'Extravasation of Diagnostic and Therapeutic Materials'}], 'ancestors': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'whyStopped': 'difficult recruiting', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2013-01-29', 'studyFirstSubmitQcDate': '2013-02-15', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average length of stay on site of the catheter measured in hours', 'timeFrame': 'participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 dayse'}], 'secondaryOutcomes': [{'measure': 'Incidence of complications extimated overall and by type of complication', 'timeFrame': 'participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 days'}, {'measure': 'Average cost for the maintenance of the catheter of each subject (pro day and in total)', 'timeFrame': 'participants will be followed for the duration on site of the first peripheral venous catheter inserted to each recruited subject, i.e. for an expected average of 10 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peripheral venous catheter, children.'], 'conditions': ['Infection of Intravenous Catheter', 'Phlebitis', 'Extravasation of Diagnostic and Therapeutic Materials']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a longer or equal duration of patency of peripheral venous catheters, compared with heparin solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge catheters Will be included in the study.The study will assess in particular:\n\n* the difference of permanence in situ of the device\n* the difference in incidence of complications (in detail: obstruction, phlebitis, thrombocytopenia, systemic anticoagulation)\n* the difference in costs between use of saline normal saline 0.9% NaCl solution and heparinized 50 U / ml.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 2 years and 14 years old\n* Medical prescription of intravenous antibiotic therapy for at least 2 doses on the day\n* Presence of informed consent to participate to the study provided by the parents\n* No known hypersensitivity to heparin\n* No known hypersensitivity to the patch fixing materials (polyurethane and / or glue)\n* Absence of diseases buoyancy coagulation (haemophilias and / or thrombophilias)\n* No antecedents trombopenie dued to the use of any type of heparin or a pentosan polysulfate\n* No existing treatment based on corticosteroids and / or anti-inflammatory\n\nExclusion Criteria:\n\n* age outside the range 2 - 14 years\n* children for which there is no prescription of intravenous antibiotic therapy for at least 2 times a day\n* children for which the parents have not consented to the study\n* children with known hypersensitivity to heparin\n* children with known hypersensitivity to the patch fixing materials (polyurethane and / or adhesive)\n* children with disease-causing buoyancy coagulation (Hemophilia and / or thrombophilia)\n* children with antecedents of trombopenie occurring by the use of any type of heparin or of a pentosan polyphosphate\n* children in treatment with corticosteroids and / or anti-inflammatory'}, 'identificationModule': {'nctId': 'NCT01794767', 'briefTitle': 'Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Florence'}, 'officialTitle': 'Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children', 'orgStudyIdInfo': {'id': 'Heparin2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0,9% NaCl flush', 'description': 'for children enrolled in this group, the nurse will perform the flushing of peripheral venous catheter using flush-solution as a bolus with saline 0.9% NaCl in the amount (ml) needed to fill the entire circuit of the catheter. The flushing will be performed routinely at the end of each fleboclisis', 'interventionNames': ['Drug: 0,9% NaCl flush']}, {'type': 'EXPERIMENTAL', 'label': 'Heparin 50U/ml', 'description': 'for children enrolled in this group, the nurse will perform the washing of peripheral venous catheter using flush-solution as a bolus with heparin 50U/ml in the amount (ml) needed to fill the entire circuit of the catheter. The washing will be performed routinely at the end of each fleboclis', 'interventionNames': ['Drug: Heparin 50U/ml']}], 'interventions': [{'name': '0,9% NaCl flush', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'description': 'Normal Saline solution', 'armGroupLabels': ['0,9% NaCl flush']}, {'name': 'Heparin 50U/ml', 'type': 'DRUG', 'otherNames': ['Heparin solution 50 U/ml, Epsodilave'], 'description': 'Heparin solution', 'armGroupLabels': ['Heparin 50U/ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50139', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'Meyer Children Hospital', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'overallOfficials': [{'name': 'Filippo Festini, RN, BSN, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florence'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florence', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nursing', 'investigatorFullName': 'Filippo Festini', 'investigatorAffiliation': 'University of Florence'}}}}