Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-29 @ 8:30 PM
Study NCT ID:
NCT01187004
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2010-08-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extracardiac Complications After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'daniela.pasero@unito.it', 'phone': '00390116335511', 'title': 'Dr Daniela Pasero', 'organization': 'UTurin'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The main limitation of the trial was the observational nature and the relatively small number of patients'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Acute Lung Injury (ALI) Group', 'description': 'patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': "patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass", 'otherNumAtRisk': 144, 'otherNumAffected': 0, 'seriousNumAtRisk': 144, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acute Lung Injury After Cardiac Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Acute Lung Injury', 'description': 'Patients who developed acute lung injury (ALI) after cardiac surgery and during mechanical ventilation'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '16'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'groupDescription': 'Our hypothesis was that mechanical ventilation with large tidal volume might represent a risk factor for acute lung injury in patients undergoing cardiopulmonary bypass.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'significant level for inclusion at the univariate analysis was p\\<0.05.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at seven days after intervention', 'description': 'to evaluate the incidence of acute lung injury (ALI) in patients undergoing cardiac surgery with cardiopulmonary by pass and to identify the main predictors.Diagnosis of Acute Lung Injury (ALI) was made according to the American-European Consensus conference criteria, including acute onset, PaO2 /FiO2 \\<300 regardless of Positive End Expiratory Pressure (PEEP) level, bilateral and diffuse opacities on chest radiograph, absence of left ventricular failure, or history of lung disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients consecutively admitted to the cardiac Intensive Care Unit (cICU) after cardiac surgery on cardiopulmonary by pass (CPB), during a time frame of two years.The analysis was per protocol, to identify the predictors of acute lung injury after cardiac surgery.'}, {'type': 'SECONDARY', 'title': 'Intensive Care Unit (ICU) Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ICU-LOS in Patients Developing ALI', 'description': 'Intensive care unit length of stay in patients developing acute lung injury. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value'}, {'id': 'OG001', 'title': 'Control Group', 'description': "patients who didn't develope ALI. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value"}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '54', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '26'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '26'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.199', 'ciLowerLimit': '1.129', 'ciUpperLimit': '1.272', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'at 28 days', 'description': 'If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of the Intensive Care Unit (ICU) length of stay was done on all the patients included in the study. We want to evaluate if the development of acute lung injury prolongs the intensive care unit length of stay.ICU length of stay was calculated up to 28 days,and patients who died before were considered as having the maximum value'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acute Lung Injury (ALI) Group', 'description': 'patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass'}, {'id': 'FG001', 'title': 'Control Group', 'description': "patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'We enrolled all patients undergoing a cardiac surgery intervention on cardiopulmonary by pass (CPB)', 'preAssignmentDetails': 'Patients were excluded for: Intensive Care Unit - Length of stay (ICU-LOS)\\<24h, age \\< 18 yrs old; mechanical ventilation before surgery; Acute Lung Injury (ALI) at the admission to Intensive Care Unit (ICU); heart and lung transplant'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acute Lung Injury (ALI) Group', 'description': 'patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass'}, {'id': 'BG001', 'title': 'Control Group', 'description': "patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '10', 'groupId': 'BG000'}, {'value': '65', 'spread': '14', 'groupId': 'BG001'}, {'value': '66', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-05', 'studyFirstSubmitDate': '2010-08-19', 'resultsFirstSubmitDate': '2011-08-08', 'studyFirstSubmitQcDate': '2010-08-20', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-30', 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Lung Injury After Cardiac Surgery', 'timeFrame': 'at seven days after intervention', 'description': 'to evaluate the incidence of acute lung injury (ALI) in patients undergoing cardiac surgery with cardiopulmonary by pass and to identify the main predictors.Diagnosis of Acute Lung Injury (ALI) was made according to the American-European Consensus conference criteria, including acute onset, PaO2 /FiO2 \\<300 regardless of Positive End Expiratory Pressure (PEEP) level, bilateral and diffuse opacities on chest radiograph, absence of left ventricular failure, or history of lung disease.'}], 'secondaryOutcomes': [{'measure': 'Intensive Care Unit (ICU) Length of Stay', 'timeFrame': 'at 28 days', 'description': 'If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Lung Injury', 'Sepsis', 'Infections', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Hypothesis of the study is that patients undergoing major cardiac surgery can develop extracardiac complications correlated to cardiopulmonary by pass.', 'detailedDescription': 'To find out which are the main peri operative predictors of acute lung injury and other extracardiac complications, such as kidney injury, that prolonged Intensive Care Unit (ICU) length of stay after cardiac surgery. The main goal is to evaluate whether mechanical ventilation, in particular tidal volume, can be predictor of acute lung injure in this kind of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing major cardiac surgery with cardiopulmonary by pass', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cardiac intervention with cardiopulmonary by pass, age \\> 18 years old\n\nExclusion Criteria:\n\n* off-pump surgery, heart and lung transplantations, patients on mechanical ventilation before intervention or admitted to Intensive Care Unit (ICU) before intervention.'}, 'identificationModule': {'nctId': 'NCT01187004', 'briefTitle': 'Extracardiac Complications After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Extracardiac Complications After Cardiopulmonary by Pass in Cardiac Surgery', 'orgStudyIdInfo': {'id': '82755'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Lung Injury (ALI)', 'description': 'patients who might develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'state': 'Italy', 'country': 'Italy', 'facility': 'Cardiac Intensive Care Unit, San Giovanni Battista Hospital', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': 'Mauro Rinaldi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'San Giovanni Battista Hospital, University of Turin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Daniela Pasero', 'investigatorAffiliation': 'University of Turin, Italy'}}}}