Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-28 @ 11:50 AM
Study NCT ID:
NCT03231956
Status:
UNKNOWN
Last Update Posted:
2020-03-18
First Post:
2017-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLEAR Sepsis Clinical Study
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Laboratory specimens to be collected include blood and will be analyzed for lactate at a central clinical research laboratory (WSU Integrative Biosciences, Detroit, MI). Additionally, plasma samples will be obtained for and stored at the WSU Biobank to support potential future clinical and translational research. Samples for the purpose of the WSU Biobank are optional to the clinical research participant and will not adversely affect participation in the clinical trial.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2017-07-21', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite outcome', 'timeFrame': 'Within 72 hours of presentation', 'description': 'Increase in modified Sequential Organ Failure Assessment (mSOFA) score ≥ 1 resulting in ICU admission / death.'}, {'measure': 'Venous Blood Lactate clearance', 'timeFrame': 'Within 24 and 72 hours of presentation', 'description': 'Venous Blood Lactate clearance'}, {'measure': 'Length of Stay', 'timeFrame': '30 days', 'description': 'Emergency Department length of stay, ICU length of stay, and Hospital length of stay'}, {'measure': 'Recidivism', 'timeFrame': '30 days', 'description': 'Recidivism within 30 days of the index hospital visit'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'To investigate the relationship between initial ClearSight™ derived hemodynamic parameters and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with acute infection and possible sepsis, with a focus on venous blood lactate (\\< 2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic Group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute infection and possible sepsis, with a focus on venous blood lactate (\\< 2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic Group).', 'healthyVolunteers': False, 'eligibilityCriteria': "Venous Blood Lactate Groups\n\nInclusion Criteria:\n\n* ≥ 18 years of age at the time of enrollment\n* Any combination of acute symptoms and signs that the treating ED physician, after initial history and physical examination, attributes to a systemic infection\n* ED Physician confirms likely hospital admission (\\> 50%) due to suspicion of infection\n* ED Physician confirms intention to order both blood cultures and venous blood lactate levels\n* Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation\n\nExclusion Criteria:\n\n* Initial venous blood lactate measured \\> 3 hours after ED arrival\n* Pre-existing infection for which patient is being treated with antibiotics as an outpatient\n* Prisoners\n* Pregnant women\n* Any previous medical condition with life expectancy of \\< 3 months (patients with ESRD and heart failure are not excluded)\n* DNR or comfort care order preexisting to ED visit or established in the ED\n* Palliative care or hospice consult in the ED\n* Known severe aortic insufficiency\n* Known history of Raynaud's disease\n* Poor follow-up candidate in the opinion of the Investigator\n* Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.\n\nControl Sepsis Mimic\n\nInclusion Criteria:\n\n* ≥18 years of age at the time of enrollment\n* Presents to the ED with a chief complaint consistent with a minor infection (upper respiratory infection, soft tissue infection, viral infection) or an asthma or COPD exacerbation on whom the treating physician is not ordering labs for blood cultures or lactate levels\n* Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation.\n\nExclusion Criteria:\n\n* Pre-existing infection for which patient is being treated with antibiotics as an outpatient\n* Prisoners\n* Pregnant women\n* Any previous medical condition with life expectancy of \\< 3 months (patients with ESRD and heart failure are not excluded)\n* DNR or comfort care order preexisting to ED visit or established in the ED\n* Palliative care or hospice consult in the ED\n* Known severe aortic insufficiency\n* Known history of Raynaud's disease\n* Poor follow-up candidate in the opinion of the Investigator\n* Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.\n* Treating physician is planning on ordering either a lactate or blood cultures on the patient."}, 'identificationModule': {'nctId': 'NCT03231956', 'acronym': 'CLEAR Sepsis', 'briefTitle': 'CLEAR Sepsis Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)', 'orgStudyIdInfo': {'id': '2017-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 0', 'description': 'Control Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup.', 'interventionNames': ['Device: ClearSight™ / EV1000NI Clinical Platform']}, {'label': 'Group 1', 'description': 'Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL', 'interventionNames': ['Device: ClearSight™ / EV1000NI Clinical Platform']}, {'label': 'Group 2', 'description': 'Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL', 'interventionNames': ['Device: ClearSight™ / EV1000NI Clinical Platform']}, {'label': 'Group 3', 'description': 'Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL', 'interventionNames': ['Device: ClearSight™ / EV1000NI Clinical Platform']}], 'interventions': [{'name': 'ClearSight™ / EV1000NI Clinical Platform', 'type': 'DEVICE', 'description': 'Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System', 'armGroupLabels': ['Group 0', 'Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Paxton, MD', 'role': 'CONTACT', 'email': 'jpaxton@med.wayne.edu', 'phone': '313-993-8464'}, {'name': 'Theodore Falcon', 'role': 'CONTACT', 'email': 'tfalcon@med.wayne.edu', 'phone': '313-993-8464'}], 'facility': 'Detroit Receiving Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48235', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Sherwin, MD', 'role': 'CONTACT', 'email': 'rshewin@med.wayne.edu', 'phone': '313-966-9114'}, {'name': 'Joshua Phillips', 'role': 'CONTACT', 'email': 'jphillip@med.wayne.edu', 'phone': '313-966-9114'}], 'facility': 'Sinai-Grace Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Claire Pearson, MD', 'role': 'CONTACT', 'email': 'cpearson@med.wayne.edu', 'phone': '313-966-1829'}, {'name': 'Thomas Mazzocco', 'role': 'CONTACT', 'email': 'tmazzocc@med.wayne.edu', 'phone': '313-966-1829'}], 'facility': 'Ascension St. John Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48703', 'city': 'Royal Oak', 'state': 'Michigan', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Beaumont Hospital, Royal Oak', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Beaumont Hospital, Troy', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}], 'centralContacts': [{'name': 'Jurandir Araujo, BA', 'role': 'CONTACT', 'email': 'jurandir_araujo@edwards.com', 'phone': '949-250-5469'}, {'name': 'Ryan Zafra, BS', 'role': 'CONTACT', 'email': 'ryan_zafra@edwards.com', 'phone': '949-250-1354'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}