Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial
NCT ID: NCT04414189
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2020-06-07
2021-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Arm A
Patients with suspected sepsis at the time of admission to the ICU
HostDx Sepsis
Blood collection for mRNA analysis
Arm B
Patients not currently suspected but at high risk for sepsis.
HostDx Sepsis
Blood collection for mRNA analysis
Interventions
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HostDx Sepsis
Blood collection for mRNA analysis
Eligibility Criteria
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Inclusion Criteria
1. Age \> 18 years
2. Suspected sepsis at the time of admission to the ICU
3. Direct admission from the ED to the ICU with suspected/proven sepsis.
4. Post-operative ICU admission after sepsis source control procedure
5. Inpatients admitted to the ICU from the ward with suspected sepsis onset.
6. Able to provide subject/proxy informed consent within 96h
Arm B
1. Age \> 18 years
2. No suspicion of sepsis at the time of admission to the ICU but at high risk for subsequent sepsis onset
3. Non-trauma admission from the ED to the ICU
4. Post-operative ICU admission
5. Severe trauma admission from the ED (injury severity score \>15, hemorrhagic shock, severe traumatic brain injury, and or severe chest trauma)
6. Inpatients admitted to the ICU from the ward for decompensation not initially suspected to be secondary to sepsis.
7. Able to provide subject/proxy informed consent within 96h
Exclusion Criteria
2. Patients admitted solely for airway monitoring, or vascular/flap check monitoring
3. Previous diagnosis of sepsis on index hospitalization.
4. Unable to provide informed consent within 96h
5. Previously enrolled in the present study.
18 Years
ALL
No
Sponsors
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University of Florida
OTHER
Inflammatix
INDUSTRY
Responsible Party
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Locations
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University of Florida College of Medicine
Gainesville, Florida, United States
Countries
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Other Identifiers
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INF-06
Identifier Type: -
Identifier Source: org_study_id