CLEAR Sepsis Clinical Study

Edwards Lifesciences

Status: Unknown

Conditions: Sepsis

Treatments: Device: ClearSight™ / EV1000NI Clinical Platform

Study type: Observational

Funder types: Industry

Identifiers

NCT03231956

2017-04

Details and patient eligibility

About

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).

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Venous Blood Lactate Groups

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
• Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.

Control Sepsis Mimic

Inclusion Criteria:

• ≥18 years of age at the time of enrollment
• Presents to the ED with a chief complaint consistent with a minor infection (upper respiratory infection, soft tissue infection, viral infection) or an asthma or COPD exacerbation on whom the treating physician is not ordering labs for blood cultures or lactate levels
• Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation.

Exclusion Criteria:

• 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
• Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection.
• Treating physician is planning on ordering either a lactate or blood cultures on the patient.

Trial design

182 participants in 4 patient groups

Group 0

Description:

Control Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup.

Treatment:

Device: ClearSight™ / EV1000NI Clinical Platform

Group 1

Description:

Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL

Treatment:

Device: ClearSight™ / EV1000NI Clinical Platform

Group 2

Description:

Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL

Treatment:

Device: ClearSight™ / EV1000NI Clinical Platform

Group 3

Description:

Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL

Treatment:

Device: ClearSight™ / EV1000NI Clinical Platform