Status:
UNKNOWN
CLEAR Sepsis Clinical Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- Venous Blood Lactate Groups
- ≥ 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
- 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.
Key Trial Info
Start Date :
June 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT03231956
Start Date
June 29 2017
End Date
June 30 2022
Last Update
March 18 2020
Active Locations (5)
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1
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
2
Sinai-Grace Hospital
Detroit, Michigan, United States, 48235
3
Ascension St. John Hospital
Detroit, Michigan, United States, 48236
4
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States, 48703