Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
182 participants
OBSERVATIONAL
2017-06-29
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 0
Control Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup.
ClearSight™ / EV1000NI Clinical Platform
Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
Group 1
Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL
ClearSight™ / EV1000NI Clinical Platform
Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
Group 2
Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL
ClearSight™ / EV1000NI Clinical Platform
Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
Group 3
Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL
ClearSight™ / EV1000NI Clinical Platform
Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
Interventions
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ClearSight™ / EV1000NI Clinical Platform
Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
Eligibility Criteria
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Inclusion Criteria
* Any combination of acute symptoms and signs that the treating ED physician, after initial history and physical examination, attributes to a systemic infection
* ED Physician confirms likely hospital admission (\> 50%) due to suspicion of infection
* ED Physician confirms intention to order both blood cultures and venous blood lactate levels
* Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation
* ≥18 years of age at the time of enrollment
* 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
* Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation.
Exclusion Criteria
* Pre-existing infection for which patient is being treated with antibiotics as an outpatient
* Prisoners
* Pregnant women
* Any previous medical condition with life expectancy of \< 3 months (patients with ESRD and heart failure are not excluded)
* DNR or comfort care order preexisting to ED visit or established in the ED
* Palliative care or hospice consult in the ED
* Known severe aortic insufficiency
* Known history of Raynaud's disease
* Poor follow-up candidate in the opinion of the Investigator
* Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.
Control Sepsis Mimic
* Pre-existing infection for which patient is being treated with antibiotics as an outpatient
* Prisoners
* Pregnant women
* Any previous medical condition with life expectancy of \< 3 months (patients with ESRD and heart failure are not excluded)
* DNR or comfort care order preexisting to ED visit or established in the ED
* Palliative care or hospice consult in the ED
* Known severe aortic insufficiency
* Known history of Raynaud's disease
* Poor follow-up candidate in the opinion of the Investigator
* Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.
* Treating physician is planning on ordering either a lactate or blood cultures on the patient.
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Locations
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Detroit Receiving Hospital
Detroit, Michigan, United States
Sinai-Grace Hospital
Detroit, Michigan, United States
Ascension St. John Hospital
Detroit, Michigan, United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States
Beaumont Hospital, Troy
Troy, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-04
Identifier Type: -
Identifier Source: org_study_id
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