Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:20 PM
Study NCT ID:
NCT00209768
Status:
COMPLETED
Last Update Posted:
2008-12-01
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of In-Line Filtration in Critically Ill Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 821}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-28', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2008-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sepsis'}, {'measure': 'Thrombosis'}, {'measure': 'SIRS'}, {'measure': 'Organ failure'}, {'measure': 'Composite primary outcome including "sepsis, SIRS, thrombosis, organ failure"'}], 'secondaryOutcomes': [{'measure': 'Duration of Pediatric Intensive Care Unit stay'}, {'measure': 'Duration of overall hospital stay'}]}, 'conditionsModule': {'keywords': ['pediatric intensive care', 'critically ill children', 'in-line filtration', 'prospective randomized study', 'complications', 'sepsis', 'SIRS', 'thrombosis', 'organ failure'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '29544449', 'type': 'DERIVED', 'citation': 'Lamping F, Jack T, Rubsamen N, Sasse M, Beerbaum P, Mikolajczyk RT, Boehne M, Karch A. Development and validation of a diagnostic model for early differentiation of sepsis and non-infectious SIRS in critically ill children - a data-driven approach using machine-learning algorithms. BMC Pediatr. 2018 Mar 15;18(1):112. doi: 10.1186/s12887-018-1082-2.'}, {'pmid': '23384207', 'type': 'DERIVED', 'citation': 'Boehne M, Jack T, Koditz H, Seidemann K, Schmidt F, Abura M, Bertram H, Sasse M. In-line filtration minimizes organ dysfunction: new aspects from a prospective, randomized, controlled trial. BMC Pediatr. 2013 Feb 6;13:21. doi: 10.1186/1471-2431-13-21.'}, {'pmid': '22527062', 'type': 'DERIVED', 'citation': 'Jack T, Boehne M, Brent BE, Hoy L, Koditz H, Wessel A, Sasse M. In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med. 2012 Jun;38(6):1008-16. doi: 10.1007/s00134-012-2539-7. Epub 2012 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of in-line filtration shows any effect on the outcome of sepsis, systemic inflammatory response syndrome (SIRS), thrombosis, or organ failure in critically ill children admitted to the pediatric intensive care unit (PICU).', 'detailedDescription': 'Scientific background:\n\nParticulate contamination of infusion solutions and their systemic administration during infusion therapy has been linked to various clinical problems.\n\nOrgan failure and Multi-Organ Failure (MOV):\n\nIt is well established that the pathophysiology of MOV involves deteriorations of the microcirculation and integrity of endothelial cells. As a consequence of this an imbalance between pro- and anticoagulatory factors may develop and microthrombi may form. Mediators like tissue factor (TF) and platelet activating factor (PAF) have been linked to the formation of microthrombi.\n\nParticles have been discussed as a causative agent for this syndrome by various authors. Their effect on morbidity and mortality of patients has however not yet been established.\n\nParticles may have additional harmful effects:\n\n* Direct thrombogenesis by the particle material\n* Damaging endothelial cells in the capillary network\n* Embolisation of the pulmonary vasculature\n* Acting as a cristallisation focus for the development of granuloma\n* Promoting the formation of Giant Cells\n\nVarious authors have shown that the use of end line infusion filters significantly reduces the rate of thrombophlebitis. A recently published study by van Lingen et al. (2004) also showed that the use of end line infusion filters significantly reduced the rate of overall complications in neonates.\n\nStudy Hypothesis:\n\nThe use of end line positively charged 0.2 µm and uncharged 1.2 µm infusion filters will prevent particles, microorganisms and their endotoxins from the infusate to enter the patient\'s circulation in the study group and will reduce significantly the complication rate of these patients.\n\nThe following clinical diagnoses are defined as "Complications". They are main contributors to morbidity and mortality in intensive care wards:\n\n* catheter related thrombosis of the central veins\n* sepsis with proven infectious organisms\n* Septic syndrome without proven infectious organisms\n* Failure of one of the following organs/systems\n\n 1. Lung\n 2. Kidney\n 3. Liver\n 4. Circulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children admitted to pediatric intensive care unit (PICU)\n\nExclusion Criteria:\n\n* Suspected death within 48 hours\n* Duration of PICU stay less than 6 hours\n* Patients recruited for Simulect or Sintra Study'}, 'identificationModule': {'nctId': 'NCT00209768', 'briefTitle': 'Use of In-Line Filtration in Critically Ill Children', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children', 'orgStudyIdInfo': {'id': '3702'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Filter: NOE96E, ELD96E, NLF1E, TNA1E', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Michael Sasse, Consultant', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical School Hannover'}, {'name': 'Thomas Jack, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical School Hannover'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pall Corporation', 'class': 'OTHER'}, {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}]}}}