Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 8:50 PM
Study NCT ID:
NCT03231956
Status:
UNKNOWN
Last Update Posted:
2020-03-18
First Post:
2017-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLEAR Sepsis Clinical Study
Sponsor:
Edwards Lifesciences
Organization:
Study Overview
Official Title:
Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEAR Sepsis
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: