Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 6:33 AM
Study NCT ID:
NCT04548167
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2020-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7064}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-01', 'studyFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of bloodstream infection (BSI) in postoperative period (clinical evidence of sepsis with laboratory-confirmed bacteraemia from blood sample)', 'timeFrame': 'within 7 days after a cardiovascular surgery', 'description': 'Incidence of bloodstream infection (BSI) in postoperative period (clinical evidence of sepsis with laboratory-confirmed bacteraemia from blood sample)'}, {'measure': 'Extracorporeal circulation time during surgery (minutes)', 'timeFrame': 'one time assessment at baseline', 'description': 'Extracorporeal circulation time during surgery (minutes)'}, {'measure': 'In-hospital mortality (number) for patients with BSI vs those without BSI after a cardiovascular surgery', 'timeFrame': 'during hospital stay (usually up to 4 weeks)', 'description': 'In-hospital mortality is defined as death before discharge'}, {'measure': 'Surgical intervention rate (Incidence of cardiovascular re-operation) during the initial hospital stay (number)', 'timeFrame': 'during hospital stay (usually up to 4 weeks)', 'description': 'Surgical intervention rate (Incidence of cardiovascular re-operation) during the initial hospital stay'}], 'secondaryOutcomes': [{'measure': 'Incidence of cardiovascular events (stroke, myocardial infarction) during hospitalization', 'timeFrame': 'during hospital stay (usually up to 4 weeks)', 'description': 'Incidence of cardiovascular events during hospitalization'}, {'measure': 'Incidence of cardiovascular events (stroke, myocardial infarction) during follow-up', 'timeFrame': 'after hospital discharge until follow- up assessment (up to 10 years)', 'description': 'Incidence of cardiovascular events (stroke, myocardial infarction) during follow-up'}, {'measure': 'Incidence of cardiovascular re-operation during the follow up', 'timeFrame': 'after hospital discharge until follow- up assessment (up to 10 years)', 'description': 'Incidence of cardiovascular re-operation during the follow up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiovascular surgery', 'cardiopulmonary bypass (CPB)', 'nosocomial infection', 'early bloodstream infection', 'postoperative septicaemia'], 'conditions': ['Bloodstream Infection (BSI)']}, 'descriptionModule': {'briefSummary': 'This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.', 'detailedDescription': 'Infectious complications after cardiovascular surgery, especially in operations that use cardiopulmonary bypass (CPB), is associated with significant morbidity and increase in peri-operative mortality. Prolonged CPB usage could be predictive for early bloodstream infection following cardia surgery. This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having suffered from sepsis after cardiac surgery in a period between 2009 and 2019 will be evaluated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing cardiac surgery\n\nExclusion Criteria:\n\n* patients having active or previous endocarditis\n* patients whose causative microorganism of postoperative BSI was identical to that isolated from preoperative or intraoperative samples\n* patients with common skin colonized microorganisms, such as coagulase-negative Staphylococci, Viridans group Streptococci, Corynebacterium species, Bacillus species, Propionibacterium species, and Aerococcus species or Micrococcus species, which were isolated from only a single blood sample and without evidence of clinical sepsis, because contamination was considered.'}, 'identificationModule': {'nctId': 'NCT04548167', 'briefTitle': 'Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection', 'orgStudyIdInfo': {'id': '2020-00210; ch20Berdajs2'}}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Klinik für Herzchirurgie, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Denis Berdajs, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Herzchirurgie, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}