NCT04979767UnknownNot Applicable
Function of Circulating Exosomes in Sepsis-induced Immunosuppression
University of Kansas Medical Center1 site in 1 country80 target enrollmentStarted: April 15, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 28-day mortality
Study Overview
Brief Summary
This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 50 years with ≥ 2 chronic comorbidities
- •Highly suspected bacterial infection based on clinical or radiologic evidence
- •≥ 2 systemic inflammatory response syndrome (SIRS) criteria
- •Actual/anticipated admission to intensive care unit (ICU)
- •Anticipated length of hospital stay ≥ 5 days
Exclusion Criteria
- •Pregnancy
- •Underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, HIV infection, long-term corticosteroid use (≥ 20 mg prednisone equivalents for ≥ 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases)
- •Current immunotherapy use
- •Confirmed COVID-19 infection
Outcomes
Primary Outcomes
28-day mortality
Time Frame: From enrollment to 28 days
All-cause mortality
Secondary Outcomes
- Duration of infection(From enrollment until resolution of SIRS, up to 90 days)
- Hospital mortality(From enrollment until hospital discharge, up to 90 days)
- 90-day mortality(From enrollment to 90 days)
- Length of stay(From enrollment until hospital discharge, up to 90 days)
Investigators
Nicholas Britt
Assistant Professor
University of Kansas Medical Center
Study Sites (1)
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