Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-26 @ 12:38 AM
Study NCT ID:
NCT02475694
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Lung Injury After Cardiac Surgery: Pathogenesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma samples stored at -80 degrees of Celcius'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-16', 'studyFirstSubmitDate': '2015-05-21', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute lung injury measured as the fraction of partial pressure of oxygen divided by the fraction of inspired oxygen', 'timeFrame': 'Evaluated 72 hours after weaning from cardiopulmonary bypass (CPB)', 'description': 'Arterial blood gas analysis'}], 'secondaryOutcomes': [{'measure': 'Interleukin-1beta', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB', 'description': 'Measured in blood samples from radial artery, pulmonary artery and left atrium'}, {'measure': 'Interleukin-2', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB', 'description': 'Measured in blood samples from radial artery, pulmonary artery and left atrium'}, {'measure': 'Interleukin-4', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB', 'description': 'Measured in blood samples from radial artery, pulmonary artery and left atrium'}, {'measure': 'Interleukin-6', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB', 'description': 'Measured in blood samples from radial artery, pulmonary artery and left atrium'}, {'measure': 'Interleukin-8', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB', 'description': 'Measured in blood samples from radial artery, pulmonary artery and left atrium'}, {'measure': 'Interleukin-10', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB', 'description': 'Measured in blood samples from radial artery, pulmonary artery and left atrium'}, {'measure': 'Tumor necroting factor-alpha', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB', 'description': 'Measured in blood samples from radial artery, pulmonary artery and left atrium'}, {'measure': 'Interferon-gamma', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB', 'description': 'Measured in blood samples from radial artery, pulmonary artery and left atrium'}, {'measure': 'Granulocyte-macrophage colony-stimulating factor', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB', 'description': 'Measured in blood samples from radial artery, pulmonary artery and left atrium'}, {'measure': 'Thrombin-antithrombin complexes', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB', 'description': 'Measured in blood samples from pulmonary artery and left atrium'}, {'measure': 'Plasmin-antiplasmin complexes', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB', 'description': 'Measured in blood samples from pulmonary artery and left atrium'}, {'measure': 'D-dimer', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB', 'description': 'Measured in blood samples from pulmonary artery and left atrium'}, {'measure': 'Thrombin Fragment 1.2', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB', 'description': 'Measured in blood samples from pulmonary artery and left atrium'}, {'measure': 'Metabolomics', 'timeFrame': 'The day before surgery; the day of surgery with measurement just before connecting to , immediately after weaning from CPB, 2, 4, 8, 16 and 20 hours after weaning from CPB; and exactly 48 and 72 hours after weaning from CPB', 'description': 'Metabolomics using the NMR-technique in blood samples from radial artery, pulmonary artery and left atrium'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Lung Injury', 'Metabolic Disturbances', 'Inflammation', 'Coagulation; Intravascular', 'Postoperative; Dysfunction Following Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to visualize the inflammatory response and coagulation disorders during cardiac surgery in order to identify possible predictors for acute lung injury postoperatively.', 'detailedDescription': 'Acute lung injury after cardiac surgery is a common complication. The pathophysiology is complex and still not fully elucidate. No specific biomarkers are identified and the diagnosis is solely based on impaired oxygenation.\n\nThe purpose of the present study is to identify biomarkers of inflammation and coagulation in blood withdrawn simultaneous from the pulmonary artery and the left atrium during surgery and up to 20 hours after weaning from cardiopulmonary bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective coronary artery bypass grafting (CABG)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgery\n* CABG\n* In treatment with statins\n\nExclusion Criteria:\n\n* Acute surgery\n* Valve replacement\n* In treatment with immunodepressive drugs'}, 'identificationModule': {'nctId': 'NCT02475694', 'acronym': 'ALI', 'briefTitle': 'Acute Lung Injury After Cardiac Surgery: Pathogenesis', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Acute Lung Injury After Cardiac Surgery: Pathogenesis', 'orgStudyIdInfo': {'id': 'N-20080016'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No treatment'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bodil S Rasmussen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, PhD', 'investigatorFullName': 'Bodil Steen Rasmussen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}