Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-04 @ 12:02 AM
Study NCT ID:
NCT03913403
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2019-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Treatment's Echocardiographic Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricular Contractility at 24 hours', 'timeFrame': '24 +/- 6 Hours', 'description': 'Left Ventricular Global Longitudinal Strain'}, {'measure': 'Right Ventricular Structure at 24 hours', 'timeFrame': '24 +/- 6 hours', 'description': 'Right Ventricular End Diastolic Area to Left Ventricular End Diastolic Area Ratio'}, {'measure': 'Day 3 delta SOFA', 'timeFrame': 'at 72 hours', 'description': 'Difference between baseline and day 3 Sequential Organ Failure Assessment (SOFA) scores'}], 'secondaryOutcomes': [{'measure': 'Right Ventricular Contractility at 24 hours', 'timeFrame': '24 +/- 6 hours', 'description': 'Right Ventricular Longitudinal Strain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluid Management', 'Sepsis-Induced Hypotension', 'Vasopressors', 'Cardiac Contractility'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'This ancillary study determines whether the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) \\[ClinicalTrials.gov Identifier: NCT03434028\\] treatment arms (restrictive fluids strategy vs. liberal fluid strategy) for early sepsis-induced hypotension are associated with differences in cardiac structure and function based on an echocardiogram at 24 hours after randomization. Secondarily, this ancillary study explores possible heterogeneity of treatment effect based on an echocardiogram performed shortly after randomization in CLOVERS.', 'detailedDescription': "The Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM) study is an ancillary study to CLOVERS, a parent multi-center, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The CLOVERS trial attempts to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension. This ancillary study obtains echocardiograms among CLOVERS-enrolled patients who consent to CLOVERS-STEM at baseline and 24 hours later (secondarily, this study also measures serum troponin levels at baseline and 24 hours) to pursue three aims: 1. Evaluate for differences in left ventricular global longitudinal strain at 24 hours after randomization between treatment arms; 2. Evaluate for differences in right ventricular end diastolic area to left ventricular end diastolic area ratio at 24 hours after randomization between treatment arms; 3. Explore possible heterogeneity of treatment effect based on baseline echocardiogram."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial with no allergy to ultrasound-enhancing agents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial\n\nExclusion Criteria:\n\n* Lack of Informed Consent for this Ancillary Study\n* Allergy to Ultrasound-Enhancing Agents'}, 'identificationModule': {'nctId': 'NCT03913403', 'briefTitle': "Study of Treatment's Echocardiographic Mechanisms", 'organization': {'class': 'OTHER', 'fullName': 'Intermountain Health Care, Inc.'}, 'officialTitle': "Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM)", 'orgStudyIdInfo': {'id': '1051075'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention', 'description': "Participants will receive 2 ECHO's and 2 Blood Draws", 'interventionNames': ['Procedure: ECHO', 'Procedure: Blood Draw']}], 'interventions': [{'name': 'ECHO', 'type': 'PROCEDURE', 'description': 'Echocardiogram at baseline and 24 hours later', 'armGroupLabels': ['Intervention']}, {'name': 'Blood Draw', 'type': 'PROCEDURE', 'description': 'Blood Draw for Troponin Levels - 5ml at baseline and 24 hours later', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Somnath Bose, MD', 'role': 'CONTACT'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Gong, MD', 'role': 'CONTACT'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lane Smith, MD', 'role': 'CONTACT'}], 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Akram Khan, MD', 'role': 'CONTACT'}], 'facility': 'Oregon Health Sciences Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37235', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wesley Self, MD', 'role': 'CONTACT'}, {'name': 'Deepak Gupta, MD', 'role': 'CONTACT'}], 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samuel Brown, MD', 'role': 'CONTACT', 'email': 'Samuel.brown@imail.org', 'phone': '801-507-6556'}, {'name': 'Carlos Barbagelata, MS', 'role': 'CONTACT', 'email': 'carlos.barbagelata@imail.org', 'phone': '801-507-4607'}, {'name': 'Samuel Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sarah Beesley, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elliotte Hirshberg, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Lanspa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lindsay Leither', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Catherine Hough, MD', 'role': 'CONTACT'}, {'name': 'Nicholas Johnson, MD', 'role': 'CONTACT'}], 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Valerie Aston', 'role': 'CONTACT', 'email': 'valerie.aston@imail.org', 'phone': '801-507-4607'}, {'name': 'Carlos Barbagelata, MS', 'role': 'CONTACT', 'email': 'carlos.barbagelata@imail.org', 'phone': '801-507-4607'}], 'overallOfficials': [{'name': 'Samuel Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health Care, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'https://biolincc.nhlbi.nih.gov/home/', 'timeFrame': 'A de-identified version of the analytic data-set will be available for use 3 years after the primary publication.', 'ipdSharing': 'YES', 'description': 'Data will be collected electronically and stored at the Coordinating Center at Intermountain Medical Center. A de-identified version of the analytic data-set will be available for use 3 years after the primary publication. Data can be accessed at that point via the National Heart, Lung and Blood Institute (NHLBI) Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) data repository.', 'accessCriteria': 'Investigators who complete the appropriate registrations with the Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) will have access to the de-identified analytic dataset as per BioLINCC policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, {'name': 'Harborview Injury Prevention and Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}