Trials / Unknown
UnknownNCT03231956
CLEAR Sepsis Clinical Study
Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 182 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | ClearSight™ / EV1000NI Clinical Platform | Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System |
Timeline
- Start date
- 2017-06-29
- Primary completion
- 2021-12-31
- Completion
- 2022-06-30
- First posted
- 2017-07-27
- Last updated
- 2020-03-18
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03231956. Inclusion in this directory is not an endorsement.