Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-11 @ 7:36 PM
Study NCT ID:
NCT05066256
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2021-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pre-experimental study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-01', 'studyFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluid responsiveness', 'timeFrame': '6 hours', 'description': 'Fluid responsiveness defined by increase in cardiac output at least 15% or increase in systolic blood pressure at least 10 mmHg or increase in mean arterial pressure at least 5 mmHg.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shock', 'fluid responsiveness', 'left ventricular diastolic dysfunction', "Mitral E/e'"], 'conditions': ['Shock', 'Septic Shock']}, 'descriptionModule': {'briefSummary': "Fluid responsive is defined as increasing in Cardiac output or Stroke volume by 10-15% after fluid challenge. Left ventricular diastolic dysfunction is associated with lower left ventricular end-diastolic volume (LVEDV) resulting in a less cardiac output increment after fluid challenge. However, Left ventricular diastolic function indicated by the Mitral E/e' ratio from transthoracic echocardiography, was rarely studied for fluid responsiveness evaluation.", 'detailedDescription': "Fluid therapy is one of the main treatments in patients with shock to increase Oxygen delivery by increasing Cardiac output or Stroke volume. However excess fluid intake may cause fluid overload, resulting in tissue edema, lung edema and organ dysfunction, which can lead to patient deterioration.\n\nFluid responsiveness, defined as increasing in Cardiac output or Stroke volume by 10-15% after fluid challenge, is being recommended to evaluate in-patients with shock, according to European Society of Intensive Care Medicine (ESICM). Cardiac output measurement is often invasive or requires an expensive device, therefore, tests for predicting fluid responsiveness have been used to substitute direct Cardiac output measurement.\n\nLeft ventricular diastolic dysfunction is associated with a decreasing Left ventricular end-diastolic volume, resulting in a less cardiac output increment after fluid challenge and can be measured by using Mitral E/e' ratio via transthoracic echocardiography.\n\nDespite being a non-invasive test, the Mitral E/e' ratio obtained from Echocardiography was rarely studied for the prediction of fluid responsiveness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18 years\n* Diagnosis of shock defined by systolic blood pressure \\< 90 mmHg or mean arterial blood pressure \\< 65 mmHg and/or clinical hypoperfusion\n* Mechanically ventilated without ventilator dyssynchrony and no ventilator triggering\n* Present of central venous cather or arterial catheter\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Frankly hypovolemic shock or hemorrhagic shock\n* Suspicious of cardiogenic shock\n* Suspicious of acute decompensated heart failure\n* Suspicious of acute coronary syndrome\n* Denied participation or denied inform consent'}, 'identificationModule': {'nctId': 'NCT05066256', 'briefTitle': 'LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Left Ventricular Diastolic Function Compare to Inferior Vena Cava Diameter Variation as Predictor of Fluid Responsiveness in Mechanical Ventilated Patients With Shock', 'orgStudyIdInfo': {'id': 'Si 752/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluid responsive test', 'description': "Measure cardiac output, inferior vena cava (IVC) diameter variation and LV diastolic function (E/e') baseline Fluid challenge Measure cardiac output, IVC diameter variation and LV diastolic function (E/e') after fluid challenge", 'interventionNames': ['Diagnostic Test: Left ventricular diastolic function', 'Diagnostic Test: Inferior vena cava variation']}], 'interventions': [{'name': 'Left ventricular diastolic function', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ["Mitral E/e'"], 'description': "Transthoracic echocardiography Mitral E/e'", 'armGroupLabels': ['Fluid responsive test']}, {'name': 'Inferior vena cava variation', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['IVC variation'], 'description': 'Inferior vena cava variation from ultrasound', 'armGroupLabels': ['Fluid responsive test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Surat Tongyoo, MD', 'role': 'CONTACT', 'email': 'surat_Ty@yahoo.co.uk', 'phone': '6624198534'}], 'facility': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Surat Tongyoo', 'role': 'CONTACT', 'email': 'surat.ton@mahidol.ac.th', 'phone': '6624198534'}], 'overallOfficials': [{'name': 'Surat Tongyoo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Within 6 months after study publication', 'ipdSharing': 'YES', 'description': 'Anonymus participant data will be available after request with ethical committee approval.', 'accessCriteria': 'Request to principal investigator after ethical committee approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}