CLEAR Sepsis Clinical Study

  • End date
    Jun 30, 2022
  • participants needed
  • sponsor
    Edwards Lifesciences
Updated on 24 January 2021
blood culture
blood lactate
lactate level


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).

Condition Septicemia, Sepsis and Septicemia, systemic infection, systemic infections, sepsis, sepsis syndrome
Treatment ClearSight™ / EV1000NI Clinical Platform
Clinical Study IdentifierNCT03231956
SponsorEdwards Lifesciences
Last Modified on24 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Septicemia or Sepsis and Septicemia?
Do you have any of these conditions: systemic infections or sepsis syndrome or sepsis or systemic infection or Sepsis and Septicemia or Septicemia?
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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