Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT05544903
Status:
UNKNOWN
Last Update Posted:
2023-10-13
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-12', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '24 hours', 'description': 'This study will ascertain whether the patient died within 24 hours of ED arrival.'}, {'measure': 'ICU admission', 'timeFrame': '24 hours', 'description': 'This study will ascertain whether the patient was admitted to the ICU within 24 hours of ED arrival.'}, {'measure': 'Rapid response team activation', 'timeFrame': '24 hours', 'description': 'This study will ascertain whether a rapid response team was activated for the patient within 24 hours of ED arrival.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The FloPatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. This study will assess whether initial FloPatch measured volume-responsiveness and volume of fluids used will predict a composite outcome of mortality, intensive care unit admission, or rapid response team activation. The development of fluid unresponsiveness throughout the initial fluid resuscitation will be assessed and its association with the composite outcome will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the emergency department who meet sepsis criteria based on presenting vital signs will be eligible for the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency department patient\n* 18+ years old\n* Systolic blood pressure less than 100mmHg\n* Respiratory rate greater than 22 breaths per minutes\n* Temperature greater than 38 degrees Celsius or less than 36 degrees Celsius\n* Heart rate greater than 90 beats per minute\n\nExclusion Criteria:\n\n* Already intubated prior to emergency department arrival\n* Ventilator-dependent\n* Patients transferred from another hospital\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05544903', 'acronym': 'POCUS Sepsis', 'briefTitle': 'Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'The Use of Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department', 'orgStudyIdInfo': {'id': '20-0151'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mortality, ICU admission, or rapid response team activation', 'description': 'Carotid flow patterns and velocity time integral values, as determined by FloPatch.'}, {'label': 'No mortality, ICU admission, or rapid response team activation', 'description': 'Carotid flow patterns and velocity time integral values, as determined by FloPatch.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Timmy Li, PhD', 'role': 'CONTACT', 'email': 'tli2@northwell.edu', 'phone': '516-240-3933'}, {'name': 'Allison Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Rolston, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Jafari, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'centralContacts': [{'name': 'Timmy Li, PhD', 'role': 'CONTACT', 'email': 'tli2@northwell.edu', 'phone': '516-240-3933'}], 'overallOfficials': [{'name': 'Allison Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Shore University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Flosonics Medical', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}