CLEAR Sepsis Clinical Study
Status unconfirmed
Conditions studied: Sepsis
In brief
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).
Key facts
- Study ID
- NCT03231956
- Run by
- Edwards Lifesciences
- People needed
- 182
- Starts
- 2017-06-29
- Expected to finish
- 2022-06-30
- Last updated by the study team
- 2020-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- Detroit Receiving Hospital — Detroit, Michigan, United States (enrolling)
- Sinai-Grace Hospital — Detroit, Michigan, United States (enrolling)
- Ascension St. John Hospital — Detroit, Michigan, United States (enrolling)
- Beaumont Hospital, Royal Oak — Royal Oak, Michigan, United States
- Beaumont Hospital, Troy — Troy, Michigan, United States
Full record on ClinicalTrials.gov
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