Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT02239705
Status:
UNKNOWN
Last Update Posted:
2014-09-15
First Post:
2014-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mathematical Coupling of Data in Transpulmonary Thermodilution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-11', 'studyFirstSubmitDate': '2014-09-10', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cardiac Output', 'timeFrame': 'Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents', 'description': 'To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, cardiac output will be assessed before and after 20 minutes starting infusion.'}, {'measure': 'Change in Global end diastolic volume', 'timeFrame': 'Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents', 'description': 'To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, global end diastolic volume will be assessed before and after 20 minutes starting infusion.'}, {'measure': 'Change Left ventricular volume', 'timeFrame': 'Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents', 'description': 'To evaluate the change in cardiac function after therapeutic, life-saving fluid resuscitation or vasopressor agent infusion, Left ventricular volume measurement with echocardiography will be evaluated before and after 20 minutes starting infusion.'}, {'measure': 'Change Right ventricular volume', 'timeFrame': 'Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents', 'description': 'To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, Right Ventricular Volume measurement with echocardiography will be assessed before and after 20 minutes starting infusion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Trans pulmonary thermodilution', 'Hemodynamic'], 'conditions': ['Critical Illness']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.anestesia.unifg.it/Segreteria-e-Contatti/179/', 'label': 'Speciality school of anesthesia of University of Foggia'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether cardiac output (CO) and global end diastolic volume (GEDV) determined from the same thermodilution curve by EV1000 are mathematically coupled during the infusion of fluid or inotropic agents in critically ill patients.', 'detailedDescription': 'Some fundamental questions remain unanswered about the mathematical analysis of the thermodilution curve and the physiological significance of the Global End Diastolic Volume ( GEDV ) .\n\nThe mathematical derivation of the Global End Diastolic Volume (GEDV) is intimately linked with the Cardiac Output (CO), because EV1000, to calculate the GEDV, uses a formula in which the CO is the term "flow " for both the calculations of Volume Thermal Intra Thoracic (ITTV) and Lung Thermal volume (PTV) .\n\nThe clinical validation of GEDV as an index of preload has been substantially based on measuring changes in GEDV and CO in response to the Fluid Challenge only in patients "volume responsive".\n\nIn this scenario, GEDV and CO may show a close correlation only on the basis of their mathematical derivation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient admitted in the Intensive Care Department\n* patient monitored by EV1000 trans pulmonary device\n* Systolic blood pressure (SBP) less than 90 mm Hg or SBP Drop ≥ 40 mm Hg of normal\n* decision by 1 expert intensivist physician to initiate fluid resuscitation hospital protocol or therapeutic infusion of vasopressor agent\n\nExclusion Criteria:\n\n* pregnancy\n* age less than 18'}, 'identificationModule': {'nctId': 'NCT02239705', 'briefTitle': 'Mathematical Coupling of Data in Transpulmonary Thermodilution', 'organization': {'class': 'OTHER', 'fullName': 'University of Foggia'}, 'officialTitle': 'Mathematical Coupling of Data Between Global-End Diastolic Volume Index and Cardiac Index Calculated by Edwards EV1000', 'orgStudyIdInfo': {'id': 'A02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fluid challenge', 'description': 'Patients whose clinical conditions require bolus of fluids infusion to correct blood pressure and cardiac output'}, {'label': 'Inotropic infusion', 'description': 'Patient whose clinical conditions require inotropic agents infusion to correct blood pressure and cardiac output'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70100', 'city': 'Foggia', 'state': 'FG', 'country': 'Italy', 'contacts': [{'name': 'Mauro Salaris, Segretary', 'role': 'CONTACT', 'email': 'anestesia.rianimazione@unifg.it', 'phone': '0881.732387'}, {'name': 'Livio Tullo, Medic', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michele Dambrosio, medic', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alberto Sciusco, medic', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedali Riuniti', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}], 'centralContacts': [{'name': 'Alberto Sciusco, Doctor', 'role': 'CONTACT', 'email': 'albertsciusc@gmail.com', 'phone': '0039 329 0408320'}], 'overallOfficials': [{'name': 'Michele Dambrosio, Medic', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Foggia'}, {'name': 'Livio Tullo, Medic', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Foggia'}, {'name': 'Alberto Sciusco, medic', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Foggia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Foggia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Alberto Sciusco', 'investigatorAffiliation': 'University of Foggia'}}}}