Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT04635293
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2020-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Retrospective'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-12', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hours of mechanical ventilation', 'timeFrame': 'during stay in ICU, approximately 48 hours postoperatively', 'description': 'hours of mechanical ventilation during patient stay in Intensive Care Unit (ICU)'}, {'measure': 'vasopressor use in operating room', 'timeFrame': 'intraoperatively, from induction to end of anesthesia, an average period of 3 hours', 'description': 'need for vasopressor use, yes or no'}, {'measure': 'vasopressor use in ICU', 'timeFrame': 'during stay in ICU, approximately 48 hours postoperatively', 'description': 'need for vasopressor use, yes or no'}, {'measure': 'inotrope use in operating room', 'timeFrame': 'intraoperatively, from induction to end of anesthesia, an average period of 3 hours', 'description': 'need for inotrope use, yes or no'}, {'measure': 'inotrope use in ICU', 'timeFrame': 'during stay in ICU, approximately 48 hours postoperatively', 'description': 'need for inotrope use, yes or no'}, {'measure': 'incidence of arrhythmias', 'timeFrame': 'postoperatively, an average period of 7-10 days', 'description': 'development of new-onset arrhythmias, yes or no'}, {'measure': 'incidence of renal dysfunction', 'timeFrame': 'postoperatively, an average period of 7-10 days', 'description': 'development of new-onset renal dysfunction, defined as an increase in creatinine levels over 0.3 mg/dL from the initial values'}, {'measure': 'length of ICU stay', 'timeFrame': 'postoperatively, an average period of 7-10 days', 'description': 'duration of patient stay in ICU in days'}, {'measure': 'hospitalization time', 'timeFrame': 'postoperatively, up to 20 days after the operation', 'description': 'duration of hospital stay after surgery in days'}, {'measure': 'incidence of death within the first 30 days after surgery', 'timeFrame': '30 days after surgery', 'description': 'patient survival within the first 30 days after surgery, yes or no'}, {'measure': 'need of mechanical assist devices intraoperatively', 'timeFrame': 'intraoperatively, from induction to end of anesthesia, an average period of 3 hours and postoperatively, an average period of 7-10 days', 'description': 'need for mechanical assist devices, yes or no'}, {'measure': 'need of mechanical assist devices postoperatively', 'timeFrame': 'postoperatively, an average period of 7-10 days', 'description': 'need for mechanical assist devices, yes or no'}, {'measure': 'change from baseline in cardiac output (CO)', 'timeFrame': '10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,', 'description': 'a Swan-Ganz catheter will be used for hemodynamic measurements'}, {'measure': 'change from baseline in mean arterial pressure (MAP)', 'timeFrame': '10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,', 'description': 'a Swan-Ganz catheter will be used for hemodynamic measurements'}, {'measure': 'change from baseline in mean pulmonary arterial pressure (MPAP)', 'timeFrame': '10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,', 'description': 'a Swan-Ganz catheter will be used for hemodynamic measurements'}, {'measure': 'change from baseline in systemic vascular resistance (SVR)', 'timeFrame': '10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,', 'description': 'a Swan-Ganz catheter will be used for hemodynamic measurements'}, {'measure': 'change from baseline in pulmonary vascular resistance (PVR)', 'timeFrame': '10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,', 'description': 'a Swan-Ganz catheter will be used for hemodynamic measurements'}, {'measure': 'change from baseline in pulmonary capillary wedge pressure (PCWP)', 'timeFrame': '10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery),12 hours after ICU admittance, 24 hours after ICU admittance,', 'description': 'a Swan-Ganz catheter will be used for hemodynamic measurements'}, {'measure': 'change from baseline in cardiac function', 'timeFrame': '10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery)', 'description': 'transesophageal echocardiography will be used for echocardiographic measurements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['levosimendan', 'low output syndrome'], 'conditions': ['Cardiac Disease', 'Cardiac Failure', 'Cardiac Surgery', 'Inotropes', 'Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '17702589', 'type': 'BACKGROUND', 'citation': 'Tasouli A, Papadopoulos K, Antoniou T, Kriaras I, Stavridis G, Degiannis D, Geroulanos S. Efficacy and safety of perioperative infusion of levosimendan in patients with compromised cardiac function undergoing open-heart surgery: importance of early use. Eur J Cardiothorac Surg. 2007 Oct;32(4):629-33. doi: 10.1016/j.ejcts.2007.07.010. Epub 2007 Aug 15.'}, {'pmid': '21963578', 'type': 'BACKGROUND', 'citation': 'Landoni G, Biondi-Zoccai G, Greco M, Greco T, Bignami E, Morelli A, Guarracino F, Zangrillo A. Effects of levosimendan on mortality and hospitalization. A meta-analysis of randomized controlled studies. Crit Care Med. 2012 Feb;40(2):634-46. doi: 10.1097/CCM.0b013e318232962a.'}, {'pmid': '19151048', 'type': 'BACKGROUND', 'citation': 'Tritapepe L, De Santis V, Vitale D, Guarracino F, Pellegrini F, Pietropaoli P, Singer M. Levosimendan pre-treatment improves outcomes in patients undergoing coronary artery bypass graft surgery. Br J Anaesth. 2009 Feb;102(2):198-204. doi: 10.1093/bja/aen367.'}, {'pmid': '17377079', 'type': 'BACKGROUND', 'citation': 'De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3.'}, {'pmid': '15725064', 'type': 'BACKGROUND', 'citation': 'Kivikko M, Lehtonen L. Levosimendan: a new inodilatory drug for the treatment of decompensated heart failure. Curr Pharm Des. 2005;11(4):435-55. doi: 10.2174/1381612053382043.'}, {'pmid': '28316276', 'type': 'BACKGROUND', 'citation': 'Mehta RH, Leimberger JD, van Diepen S, Meza J, Wang A, Jankowich R, Harrison RW, Hay D, Fremes S, Duncan A, Soltesz EG, Luber J, Park S, Argenziano M, Murphy E, Marcel R, Kalavrouziotis D, Nagpal D, Bozinovski J, Toller W, Heringlake M, Goodman SG, Levy JH, Harrington RA, Anstrom KJ, Alexander JH; LEVO-CTS Investigators. Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery. N Engl J Med. 2017 May 25;376(21):2032-2042. doi: 10.1056/NEJMoa1616218. Epub 2017 Mar 19.'}, {'pmid': '28787507', 'type': 'BACKGROUND', 'citation': 'Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, Miguet B, Guinet P, Levy F, Squara P, Ait Hamou N, Carillion A, Boyer J, Boughenou MF, Rosier S, Robin E, Radutoiu M, Durand M, Guidon C, Desebbe O, Charles-Nelson A, Menasche P, Rozec B, Girard C, Fellahi JL, Pirracchio R, Chatellier G; -. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):548-556. doi: 10.1001/jama.2017.9973.'}, {'pmid': '21784540', 'type': 'BACKGROUND', 'citation': 'Papp Z, Edes I, Fruhwald S, De Hert SG, Salmenpera M, Leppikangas H, Mebazaa A, Landoni G, Grossini E, Caimmi P, Morelli A, Guarracino F, Schwinger RH, Meyer S, Algotsson L, Wikstrom BG, Jorgensen K, Filippatos G, Parissis JT, Gonzalez MJ, Parkhomenko A, Yilmaz MB, Kivikko M, Pollesello P, Follath F. Levosimendan: molecular mechanisms and clinical implications: consensus of experts on the mechanisms of action of levosimendan. Int J Cardiol. 2012 Aug 23;159(2):82-7. doi: 10.1016/j.ijcard.2011.07.022. Epub 2011 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery', 'detailedDescription': 'Patients with severely reduced left ventricular ejection fraction (LVEF) face a high risk of morbidity and mortality after cardiac surgery. Impaired cardiac function preoperatively predisposes patients to low cardiac output syndrome. Levosimendan acts by a different mechanism than traditional inotropes and its preoperative use could improve the outcome of patients with cardiac failure. Specifically, it promotes vasodilation of coronary, pulmonary and systemic vessels, has an anti-inflammatory and anti-oxidant effect and enhances cardiac contractility by improving the response of the myofilaments to intracellular calcium.\n\nThe aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective cardiac surgery\n* cardiac surgery under cardiopulmonary bypass\n* low ejection fraction (\\<40%)\n\nExclusion Criteria:\n\n* age \\<18 years old\n* urgent operation\n* glomerular filtration rate\\<30 ml/min\n* hepatic dysfunction preoperatively\n* side effects (hypotension, tachycardia, ST segment abnormalities during levosimendan administration\n* redo surgery'}, 'identificationModule': {'nctId': 'NCT04635293', 'briefTitle': 'Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aretaieion University Hospital'}, 'officialTitle': 'Preoperative Infusion of Levosimendan in High Risk Cardiac Surgery Patients: A Retrospective Study', 'orgStudyIdInfo': {'id': '667/24.02.2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patients who were administered levosimendan at a dose of 0.1µg/Kg/min for 24 hours prior to surgery', 'interventionNames': ['Procedure: preoperative infusion of levosimendan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'patients who were not administered levosimendan prior to surgery', 'interventionNames': ['Procedure: no preoperative infusion of levosimendan']}], 'interventions': [{'name': 'preoperative infusion of levosimendan', 'type': 'PROCEDURE', 'description': 'the study group will consist of patients who have received a continuous infusion of levosimendan 0.1 μg/kg/min for 24 hours before cardiac surgery', 'armGroupLabels': ['patients who were administered levosimendan at a dose of 0.1µg/Kg/min for 24 hours prior to surgery']}, {'name': 'no preoperative infusion of levosimendan', 'type': 'PROCEDURE', 'description': 'the control group will consist of patients who proceeded to the cardiac operation without any infusion for 24 hours preoperatively', 'armGroupLabels': ['patients who were not administered levosimendan prior to surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17674', 'city': 'Athens', 'country': 'Greece', 'facility': 'Onassis Cardiac Surgery Center', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Kassiani Theodoraki, PhD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aretaieion University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aretaieion University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Dr Kassiani Theodoraki', 'investigatorAffiliation': 'Aretaieion University Hospital'}}}}