Last updated on January 2019

CLEAR Sepsis Clinical Study


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Septicemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Control (Group 0)

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 and prior to administration of 500cc of fluid

Exclusion Criteria:

  • > 500cc IV fluid bolus received
  • Initial venous blood lactate measured > 3 hours after ED arrival
  • 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
  • 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 (Group 1, 2 and 3)

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 and prior to administration of 500cc of fluid

Exclusion Criteria:

  • > 500cc IV fluid bolus received
  • 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
  • Poor follow-up candidate in the opinion of the Investigator

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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