Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-29 @ 11:40 AM
Study NCT ID:
NCT00800306
Status:
COMPLETED
Last Update Posted:
2009-10-15
First Post:
2008-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Levosimendan on Microcirculation in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077464', 'term': 'Simendan'}, {'id': 'D004280', 'term': 'Dobutamine'}], 'ancestors': [{'id': 'D006835', 'term': 'Hydrazones'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011724', 'term': 'Pyridazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-14', 'studyFirstSubmitDate': '2008-12-01', 'studyFirstSubmitQcDate': '2008-12-01', 'lastUpdatePostDateStruct': {'date': '2009-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI)', 'timeFrame': 'over a period of 36 hrs from the time of randomization'}], 'secondaryOutcomes': [{'measure': 'Acid-base homeostasis', 'timeFrame': 'over a period of 36 hrs from the time of randomization'}, {'measure': 'Oxygen transport variables', 'timeFrame': 'over a period of 36 hrs from the time of randomization'}, {'measure': 'Functional capillary density (mm/mm2) (FCD)', 'timeFrame': 'over a period of 36 hrs from the time of randomization'}, {'measure': 'De Backer score', 'timeFrame': 'over a period of 36 hrs from the time of randomization'}, {'measure': 'Perfused Vessel Density (PVD) (mm/mm2)', 'timeFrame': 'over a period of 36 hrs from the time of randomization'}, {'measure': 'Proportion of Perfused vessels (%) (PPV)', 'timeFrame': 'over a period of 36 hrs from the time of randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sepsis', 'septic shock', 'microcirculation', 'levosimendan', 'dobutamine', 'inotropes', 'inhaled nitric oxide'], 'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '21182783', 'type': 'DERIVED', 'citation': 'Morelli A, Donati A, Ertmer C, Rehberg S, Lange M, Orecchioni A, Cecchini V, Landoni G, Pelaia P, Pietropaoli P, Van Aken H, Teboul JL, Ince C, Westphal M. Levosimendan for resuscitating the microcirculation in patients with septic shock: a randomized controlled study. Crit Care. 2010;14(6):R232. doi: 10.1186/cc9387. Epub 2010 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'The present study was conducted as a prospective, randomized, controlled study to:\n\n* investigate the effects of a combination of levosimendan and inhaled nitric oxide on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock;\n* test the hypothesis that levosimendan plus inhaled nitric oxide may be effective in restoring microvascular function in septic shock.', 'detailedDescription': "40 septic shock patients requiring norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. After an initial hemodynamic resuscitation aimed at achieve a mean arterial pressure between 65 and 75 mmHg and a mixed venous oxygen saturation (SvO2) ≥ 65%, patients will be randomly allocated to be treated with either a) intravenous administration of levosimendan 0.2 µg∙kg-1∙min-1 for 24 hrs, b)intravenous administration of dobutamine 5 µg∙kg-1∙min-1 for 36 hrs(control; each n = 20). At the end of the first 24 hrs of the study period, both groups will receive inhaled nitric oxide at the concentration of 35 ppm for further 12 hrs. In all patients norepinephrine was titrated to maintain mean arterial pressure between 65 and 75 mmHg. Data from right heart catheterization and sublingual microvascular network will be obtained just before randomization (baseline) and then after 24 and 36 hours.\n\nThe sublingual microvascular network will be studied using the sidestream dark field (SDF) imaging. The device will be applied on the lateral side of the tongue, in an area approximately 2-4 cm from the tip of the tongue. Sequences of 10 secs from eight adjacent areas will be recorded on disk using a personal computer. These sequences will be later analyzed by an investigator blinded to the patient's diagnosis and therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Septic shock\n* Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)\n\nExclusion Criteria:\n\n* Pregnancy\n* Age \\< 18 years\n* Ventricular outflow tract obstruction\n* Mitral valve systolic anterior motion'}, 'identificationModule': {'nctId': 'NCT00800306', 'briefTitle': 'Effects of Levosimendan on Microcirculation in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Levosimendan and Inhaled Nitric Oxide for Resuscitating the Microcirculation in Septic Shock. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'levosimendan', 'interventionNames': ['Drug: Levosimendan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: dobutamine']}], 'interventions': [{'name': 'Levosimendan', 'type': 'DRUG', 'description': 'Intravenous administration of Levosimendan 0,2 µg•kg-1•min-1 for 24 hrs followed by the addition of 35 ppm of inhaled nitric oxide', 'armGroupLabels': ['levosimendan']}, {'name': 'dobutamine', 'type': 'DRUG', 'description': 'Intravenous administration of dobutamine 5 µg•kg-1•min-1 for 36 hrs. At the end of the first 24 hrs drug infusion, inhaled nitric oxide at the concentration of 35 ppm will be added for further 12 hrs.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Andrea Morelli, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Andrea Morelli', 'oldOrganization': 'University of Rome "La Sapienza"'}}}}