CLEAR Sepsis Clinical Study

Study Overview
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Brief Summary
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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).

Official Title
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Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)

Conditions
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Sepsis

Intervention / Treatment
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* Device: ClearSight™ / EV1000NI Clinical Platform


Participation Criteria
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Eligibility Criteria
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Venous Blood Lactate Groups Inclusion Criteria: ≥ 18 years of age at the time of enrollment 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 Exclusion Criteria: Initial venous blood lactate measured > 3 hours after ED arrival 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 Inclusion Criteria: ≥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. Treating physician is planning on ordering either a lactate or blood cultures on the patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 0<br>Control Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup. | Device: ClearSight™ / EV1000NI Clinical Platform<br>* Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System<br>|
| Group 1<br>Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL | Device: ClearSight™ / EV1000NI Clinical Platform<br>* Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System<br>|
| Group 2<br>Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL | Device: ClearSight™ / EV1000NI Clinical Platform<br>* Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System<br>|
| Group 3<br>Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL | Device: ClearSight™ / EV1000NI Clinical Platform<br>* Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome | Increase in modified Sequential Organ Failure Assessment (mSOFA) score ≥ 1 resulting in ICU admission / death. | Within 72 hours of presentation | 
| Venous Blood Lactate clearance | Venous Blood Lactate clearance | Within 24 and 72 hours of presentation | 
| Length of Stay | Emergency Department length of stay, ICU length of stay, and Hospital length of stay | 30 days | 
| Recidivism | Recidivism within 30 days of the index hospital visit | 30 days |