Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 5:37 PM
Study NCT ID:
NCT05702333
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2023-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-01-18', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need of postoperative vasoactive support after LUTX', 'timeFrame': 'February 2017 - July 2022', 'description': 'This outcome aims to describe the number of patients treated with vasoactive drugs after Lung Transplantation in Intensive Care Unit, and median dosage and duration of therapy.'}, {'measure': 'Postoperative vasoactive support use after LUTX risk factors.', 'timeFrame': 'February 2017 - July 2022', 'description': 'This outcome aims to assess if preoperative characteristics or intraoperative events can represent risk or protecting factors for postoperative vasoactive drugs need.'}, {'measure': 'Vasoactive support after LUTX impacts on outcomes.', 'timeFrame': 'February 2017 - July 2022', 'description': 'This outcome aims to assess if the vasoactive drug use in the postoperative management of Lung Transplanted patients impacts 1) mechanical ventilation duration; 2) Continuous Renal Replacement Therapy; 3) ICU and Hospital Length of Stay; 4) Primary Graft Dysfunction; 5) in-hospital mortality; 6) survival at July 31st, 2023.'}], 'secondaryOutcomes': [{'measure': 'Description of Levosimendan use in post-operative LUTX patients.', 'timeFrame': 'February 2017 - July 2022', 'description': 'This outcome aims to describe the number and the characteristics of patients treated with levosimendan.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Transplant', 'Vasoactive drugs'], 'conditions': ['Lung Transplant; Complications']}, 'referencesModule': {'references': [{'pmid': '9515837', 'type': 'BACKGROUND', 'citation': 'Mal H, Dehoux M, Sleiman C, Boczkowski J, Leseche G, Pariente R, Fournier M. Early release of proinflammatory cytokines after lung transplantation. Chest. 1998 Mar;113(3):645-51. doi: 10.1378/chest.113.3.645.'}, {'pmid': '34910811', 'type': 'BACKGROUND', 'citation': 'Di Nardo M, Tikkanen J, Husain S, Singer LG, Cypel M, Ferguson ND, Keshavjee S, Del Sorbo L. Postoperative Management of Lung Transplant Recipients in the Intensive Care Unit. Anesthesiology. 2022 Mar 1;136(3):482-499. doi: 10.1097/ALN.0000000000004054.'}, {'pmid': '2189661', 'type': 'BACKGROUND', 'citation': 'Todd TR. Early postoperative management following lung transplantation. Clin Chest Med. 1990 Jun;11(2):259-67.'}, {'pmid': '16386607', 'type': 'BACKGROUND', 'citation': 'Guillen RV, Briones FR, Marin PM, Jover AS, Represa JM, Colom AP. Lung graft dysfunction in the early postoperative period after lung and heart lung transplantation. Transplant Proc. 2005 Nov;37(9):3994-5. doi: 10.1016/j.transproceed.2005.09.193.'}]}, 'descriptionModule': {'briefSummary': 'Bilateral Lung transplantation (LUTX) is performed in selected patients with end-stage respiratory failure. During surgery, pulmonary arteries are sequentially cross-clamped. This can cause acute heart failure and hemodynamic instability that eventually persist into the postoperative period, leading to the need for prolonged vasoactive support in the postoperative Intensive Care Unit. Levosimendan is a relatively new vasoactive-inotropic drug, with different pharmacodynamic properties.\n\nThis observational retrospective cohort study primarily aims 1) to describe the need for prolonged vasoactive support; 2) to evaluate the risk factors for prolonged vasoactive support; 3) to assess the impact of prolonged vasoactive support on outcomes. The secondary aim is to describe the use of Levosimendan in this cohort of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We retrospective enrolled all consecutive patients admitted to ICU after bilateral lung transplantation from February 2017 to July 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIntensive Care Unit admission after Double Lung Transplant surgery.\n\nExclusion Criteria:\n\n1. single Lung Transplantation;\n2. re-transplantation.'}, 'identificationModule': {'nctId': 'NCT05702333', 'acronym': 'VASO_LUTX', 'briefTitle': 'Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'Postoperative Prolonged Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation: a Retrospective Analysis of Risk Factors and Impact on Outcomes', 'orgStudyIdInfo': {'id': 'VASO_LUTX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vasoactive-inotropic drug use (VASO+)', 'description': 'All patients treated with vasoactive-inotropic drugs (epinephrine, norepinephrine, dobutamine, dopamine, and levosimendan) after 12 hours after Intensive Care Unit Admission were retrospectively classified in the VASO + cohort.', 'interventionNames': ['Drug: Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan']}, {'label': 'No vasoactive-inotropic drug (VASO -)', 'description': 'Patients treated with vasoactive-inotropic drugs (epinephrine, norepinephrine, dobutamine, dopamine, and levosimendan) in the first 12 hours after Intensive Care Unit Admission (ICU) or patients never treated with such drugs in ICU were retrospectively classified in the VASO - cohort.'}], 'interventions': [{'name': 'Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan', 'type': 'DRUG', 'description': 'Vasoactive-inotropic drugs were administered according to clinical decision of the doctor in charge.', 'armGroupLabels': ['Vasoactive-inotropic drug use (VASO+)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Vittorio Scaravilli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Giacomo Grasselli', 'investigatorAffiliation': 'Policlinico Hospital'}}}}