Status:
COMPLETED
Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial
Lead Sponsor:
Inflammatix
Collaborating Sponsors:
University of Florida
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Brief Summary
This study will analyze HostDx Sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical ICU
Eligibility Criteria
Inclusion
- Arm A
- Age \> 18 years
- Suspected sepsis at the time of admission to the ICU
- Direct admission from the ED to the ICU with suspected/proven sepsis.
- Post-operative ICU admission after sepsis source control procedure
- Inpatients admitted to the ICU from the ward with suspected sepsis onset.
- Able to provide subject/proxy informed consent within 96h
- Arm B
- Age \> 18 years
- No suspicion of sepsis at the time of admission to the ICU but at high risk for subsequent sepsis onset
- Non-trauma admission from the ED to the ICU
- Post-operative ICU admission
- Severe trauma admission from the ED (injury severity score \>15, hemorrhagic shock, severe traumatic brain injury, and or severe chest trauma)
- Inpatients admitted to the ICU from the ward for decompensation not initially suspected to be secondary to sepsis.
- Able to provide subject/proxy informed consent within 96h
Exclusion
- Pre- or post-transplant patients
- Patients admitted solely for airway monitoring, or vascular/flap check monitoring
- Previous diagnosis of sepsis on index hospitalization.
- Unable to provide informed consent within 96h
- Previously enrolled in the present study.
Key Trial Info
Start Date :
June 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 19 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04414189
Start Date
June 7 2020
End Date
October 19 2021
Last Update
December 22 2021
Active Locations (1)
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1
University of Florida College of Medicine
Gainesville, Florida, United States, 32610