Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Edwards Lifesciences
- Enrollment
- 182
- Locations
- 5
- Primary Endpoint
- Venous Blood Lactate clearance
- Last Updated
- 6 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Venous Blood Lactate clearance
Time Frame: Within 24 and 72 hours of presentation
Venous Blood Lactate clearance
Composite outcome
Time Frame: Within 72 hours of presentation
Increase in modified Sequential Organ Failure Assessment (mSOFA) score ≥ 1 resulting in ICU admission / death.
Length of Stay
Time Frame: 30 days
Emergency Department length of stay, ICU length of stay, and Hospital length of stay
Recidivism
Time Frame: 30 days
Recidivism within 30 days of the index hospital visit