Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-24 @ 10:06 PM
Study NCT ID:
NCT03919604
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECMO for Lung Transplantation in Cystic Fibrosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015199', 'term': 'Extracorporeal Membrane Oxygenation'}, {'id': 'D002315', 'term': 'Cardiopulmonary Bypass'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative use of blood components', 'timeFrame': 'Jan 2013 Dec 2018', 'description': 'Intraoperative use of: 1) packed red blood cells used (units); 2) fresh frozen plasma (units); 3) pooled platelets (units)'}, {'measure': 'Length of mechanical ventilation', 'timeFrame': 'Jan 2013 Dec 2018', 'description': 'Length of invasive mechanical ventilation (days)'}, {'measure': 'Length of intensive care unit (ICU) stay', 'timeFrame': 'Jan 2013 Dec 2018', 'description': 'Intensive care unit stay (days)'}, {'measure': 'Length of Hospital stay', 'timeFrame': 'Jan 2013 Dec 2018', 'description': 'Length of hospital stay (days)'}, {'measure': 'Primary graft dysfunction', 'timeFrame': 'Jan 2013 Dec 2018', 'description': 'Primary graft dysfunction at 72 hours from re-perfusion of grafts (classes)'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Jan 2013 Dec 2018', 'description': 'survival at 31st March 2019.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'lung transplantation', 'extracorporeal membrane oxygenation'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Cystic fibrosis (CF) is the most common genetically inherited disease in the Caucasian population. Bilateral lung transplantation (LUTX) is a viable option for these patients.\n\nFrequently, the surgical operation of LUTX is complicated by hemodynamic instability, intractable hypoxia and respiratory acidosis. For these reasons, Intraoperative extracorporeal life support - ECLS- is required. Data on predictors of use of intraoperative ECLS in CF patients undergoing LUTX is scarce. Aim of this retrospective observational study was 1) to find possible risk factors at the time of enlistment associated with the intraoperative use of ECLS and 2) to compare the outcomes of CF patients treated with ECLS during LUTX or not.', 'detailedDescription': "Cystic fibrosis (CF) is the most common genetically inherited disease in the Caucasian population and damages multiple organ systems (i.e., upper and lower respiratory tract, pancreas, liver). Respiratory manifestations include reduction of mucus clearance, chronic pulmonary infections and bronchiectasis, causing progressive respiratory failure that is the primary cause of death in CF patients. Moreover, advanced CF is complicated by pulmonary hypertension, right ventricular hypertrophy and right heart failure. Bilateral lung transplantation (LUTX) is a viable option for these patients, providing a significant survival benefit as compared to no-LuTX.\n\nFrequently, the surgical operation of LUTX is complicated by acute heart failure (due to sequential pulmonary artery cross-clamping and/or hemodynamic instability), severe intractable hypoxia and respiratory acidosis. For these reasons, extracorporeal life support - ECLS - (either in the form of cardiopulmonary bypass -CBP- or extracorporeal membrane oxygenation -ECMO) is frequently required.\n\nTo now, literature data on predictors of use of intraoperative ECLS in CF patients undergoing LUTX is scarce. Notably, the use of ECLS during LUTX has been associated with a higher risk of primary graft dysfunction (PGD). Moreover, knowing that a patient has a high risk for the use of ECLS may allow appropriate clinical planning of the procedure with eventual elective ECMO connection.\n\nThe investigator's Institution (Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico) is an Italian tertiary referral center for CF and LUTX, as well as for respiratory failure and ECMO support. Aim of this retrospective observational study was 1) to find possible risk factors at the time of enlistment associated with the intraoperative use of ECLS and 2) to compare the outcomes of CF patients treated with ECLS during LUTX or not."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Any patient with CF undergoing LUTX at Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico during the study period", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CF\n* undergoing LUTX\n\nExclusion Criteria:\n\n* single lung transplantation\n* re-transplantation\n* missing medical records.'}, 'identificationModule': {'nctId': 'NCT03919604', 'acronym': 'RetroLUTX', 'briefTitle': 'ECMO for Lung Transplantation in Cystic Fibrosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'Extracorporeal Membrane Oxygenation for Lung Transplantation in Cystic Fibrosis Patients: Predictors and Impact on Outcome', 'orgStudyIdInfo': {'id': '346_2018bis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECLS group', 'description': 'Patients with CF undergoing LUTX. Need for intraoperative extracorporeal life support', 'interventionNames': ['Procedure: Extracorporeal Life Support']}, {'label': 'Non-ECLS group', 'description': 'Patients with CF undergoing LUTX. No need for intraoperative extracorporeal life support'}], 'interventions': [{'name': 'Extracorporeal Life Support', 'type': 'PROCEDURE', 'otherNames': ['Extracorporeal membrane oxygenation', 'Cardiopulmonary Bypass'], 'description': 'Any extracorporeal blood treatment technique for respiratory and/or cardiac support', 'armGroupLabels': ['ECLS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Maggiore Policlinico', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Giacomo Grasselli', 'role': 'STUDY_DIRECTOR', 'affiliation': "Universita' di Milano"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Critical Care Unit', 'investigatorFullName': 'Giacomo Grasselli', 'investigatorAffiliation': 'Policlinico Hospital'}}}}