Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-08 @ 11:40 AM
Study NCT ID:
NCT02281604
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2014-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-line Filters on ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3281}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of severe vasoplegia', 'timeFrame': 'participants will be followed for the duration of intensive care unit stay, an expected average of 1 week'}], 'secondaryOutcomes': [{'measure': 'Organ dysfunction', 'timeFrame': 'participants will be followed for the duration of intensive care unit stay, an expected average of 1 week', 'description': 'Severity of organdysfunction (SOFA-Score), incidence and severity of respiratory failure (Horovitz- Index), incidence and severity of acute kidney failure (RIFLE criteria), incidence and severity of delirium'}, {'measure': 'Inflammation', 'timeFrame': 'participants will be followed for the duration of intensive care unit stay, an expected average of 1 week', 'description': 'Interleukin-6'}, {'measure': 'Duration of ICU and hospital stay', 'timeFrame': 'participants will be followed for the duration of intensive care unit/ hospital stay, an expected average of 1 or 4 week (s), respectively'}, {'measure': 'In-hospital mortality', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'Morbidity', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks', 'description': 'Incidence of preoperative myocardial infarction, stroke, pneumonia, sepsis and acute kidney failure according to routine documentation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Micropore Filters']}, 'referencesModule': {'references': [{'pmid': '31757216', 'type': 'DERIVED', 'citation': 'Schmitt E, Meybohm P, Herrmann E, Ammersbach K, Endres R, Lindau S, Helmer P, Zacharowski K, Neb H. In-line filtration of intravenous infusion may reduce organ dysfunction of adult critical patients. Crit Care. 2019 Nov 22;23(1):373. doi: 10.1186/s13054-019-2618-z.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of 0.2/1.2 microliter in-line filter reduces the incidence of severe vasoplegia comparing to the 5 microliter filter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients, which will be treated on the anaesthesiological/surgical ICU of the University Hospital Frankfurt between 2013 - 2014', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients\n\nExclusion Criteria:\n\n* Younger than 18 years'}, 'identificationModule': {'nctId': 'NCT02281604', 'briefTitle': 'In-line Filters on ICU', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'orgStudyIdInfo': {'id': 'In-line Filter 13/14'}}, 'armsInterventionsModule': {'armGroups': [{'label': '0.2/1.2 microliter filter', 'description': 'Use of 0.2/1.2 microliter filters for intravenous drug administration'}, {'label': '5 mircroliter filter', 'description': 'Use of 5 microliter filters for intravenous drug administration'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kai Zacharowski, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Frankfurt. Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Dr. med.', 'investigatorFullName': 'Professor Kai Zacharowski, M.D., Ph.D., FRCA', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}