Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT03945708
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2019-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004696', 'term': 'Endocarditis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of vasoactive substances', 'timeFrame': '48 hours', 'description': 'Use of norepinephrine in ICU'}], 'secondaryOutcomes': [{'measure': 'Milrinone use', 'timeFrame': '48 hours', 'description': 'Amount of milrinone used 24 and 48 hours postoperatively'}, {'measure': 'Chest tube bleeding', 'timeFrame': '48 hours', 'description': 'Chest tube output in ml'}, {'measure': 'Blood transfusions', 'timeFrame': '48 hours', 'description': 'Transfusion of red blood cells, plasma and platelets'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infective Endocarditis']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the effect of addition of an adsorber during cardio pulmonary bypassin patients with infective endocarditis undergoing valve surgery, and if it will decrease the use of vasoactive drugs postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Infected endocarditis patients undergoing heart valve surgery.\n2. Age over 18 years.\n\nExclusion Criteria:\n\n1 Declines participation'}, 'identificationModule': {'nctId': 'NCT03945708', 'briefTitle': 'Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Does Whole Blood Adsorber During CPB Reduce the Amount of Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery? -a Randomized Controlled Study', 'orgStudyIdInfo': {'id': '00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Addition of whole blood adsorber to CPB circuit', 'interventionNames': ['Device: CytoSorb']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard treatment'}], 'interventions': [{'name': 'CytoSorb', 'type': 'DEVICE', 'description': 'Addition of a hemofilter to the cardiopulmonary bypass circuit', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Emma Hansson, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emma Hansson', 'class': 'OTHER'}, 'collaborators': [{'name': 'CytoSorbents, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emma Hansson', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}