Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 0 | Control Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup. |
| |
| Group 1 | Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL |
| |
| Group 2 | Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL |
| |
| Group 3 | Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearSightâ„¢ / EV1000NI Clinical Platform | Device | Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System |
|
| 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 |
Not provided
Not provided
Venous Blood Lactate Groups
Inclusion Criteria:
Exclusion Criteria:
Control Sepsis Mimic
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jurandir Araujo, BA | Contact | 949-250-5469 | jurandir_araujo@edwards.com | |
| Ryan Zafra, BS | Contact | 949-250-1354 | ryan_zafra@edwards.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit Receiving Hospital | Recruiting | Detroit | Michigan | 48201 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Laboratory specimens to be collected include blood and will be analyzed for lactate at a central clinical research laboratory (WSU Integrative Biosciences, Detroit, MI). Additionally, plasma samples will be obtained for and stored at the WSU Biobank to support potential future clinical and translational research. Samples for the purpose of the WSU Biobank are optional to the clinical research participant and will not adversely affect participation in the clinical trial.
| Sinai-Grace Hospital | Recruiting | Detroit | Michigan | 48235 | United States |
|
| Ascension St. John Hospital | Recruiting | Detroit | Michigan | 48236 | United States |
|
| Beaumont Hospital, Royal Oak | Terminated | Royal Oak | Michigan | 48703 | United States |
| Beaumont Hospital, Troy | Terminated | Troy | Michigan | 48085 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |