CLEAR Sepsis Clinical Study

• Conditions: Sepsis
• Interventions: Device: ClearSight™ / EV1000NI Clinical Platform

• Registration Number: NCT03231956
• Lead Sponsor: Edwards Lifesciences

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

Not available

Study Timeline

• Study Start: 2017-06-29
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-27
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 0	ClearSight™ / EV1000NI Clinical Platform	Control Sepsis Mimic Group (minor infections or asthma/COPD exacerbations) venous blood lactate levels are not required for this subgroup.
Group 2	ClearSight™ / EV1000NI Clinical Platform	Suspected infection plus Initial Venous Blood Lactate ≥ 2.0 - 3.9 mmol/dL
Group 3	ClearSight™ / EV1000NI Clinical Platform	Suspected infection plus Initial Venous Blood Lactate ≥ 4.0 mmol/dL
Group 1	ClearSight™ / EV1000NI Clinical Platform	Suspected infection plus Initial Venous Blood Lactate ≥ 0 - 1.9 mmol/dL

Primary Outcome Measures

Name	Time	Method
Length of Stay	30 days	Emergency Department length of stay, ICU length of stay, and Hospital length of stay
Recidivism	30 days	Recidivism within 30 days of the index hospital visit
Venous Blood Lactate clearance	Within 24 and 72 hours of presentation	Venous Blood Lactate clearance
Composite outcome	Within 72 hours of presentation	Increase in modified Sequential Organ Failure Assessment (mSOFA) score ≥ 1 resulting in ICU admission / death.

Trial Locations

Locations (5)

Beaumont Hospital, Troy; 🇺🇸 Troy, Michigan, United States

Beaumont Hospital, Royal Oak; 🇺🇸 Royal Oak, Michigan, United States

Detroit Receiving Hospital; 🇺🇸 Detroit, Michigan, United States

Sinai-Grace Hospital; 🇺🇸 Detroit, Michigan, United States

Ascension St. John Hospital; 🇺🇸 Detroit, Michigan, United States