Clinical trial NCT03231956: CLEAR Sepsis Clinical Study
Official title: Noninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2017-07-27
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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).

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).


Eligibility 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.

Primary outcomes:
measure: Composite outcome
timeFrame: Within 72 hours of presentation
measure: Venous Blood Lactate clearance
timeFrame: Within 24 and 72 hours of presentation
measure: Length of Stay
timeFrame: 30 days
measure: Recidivism
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Detroit
country: United States
facility: Sinai-Grace Hospital
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital, Royal Oak
state: Michigan
city: Troy
country: United States
facility: Beaumont Hospital, Troy
state: Michigan
Study officials:
References: