CLEAR Sepsis Clinical Study
NCT03231956 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 182
Last updated 2020-03-18
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).
Conditions
Interventions
- DEVICE
-
ClearSight™ / EV1000NI Clinical Platform
Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
Sponsors & Collaborators
-
Edwards Lifesciences
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-29
- Primary Completion
- 2021-12-31
- Completion
- 2022-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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