Sepsis, Sepsis Bacteremia, Sepsis Bacterial, Sepsis, Severe, Sepsis Syndrome, Septic Shock
Conditions
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.
Interventions
None listed
Sponsors
University of Kansas
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | From enrollment to 28 days | All-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital mortality | From enrollment until hospital discharge, up to 90 days | All-cause mortality |
| 90-day mortality | From enrollment to 90 days | All-cause mortality |
| Length of stay | From enrollment until hospital discharge, up to 90 days | Hospital length of stay |
| Duration of infection | From enrollment until resolution of SIRS, up to 90 days | Time to resolution of infection |
Countries
United States
Contacts
Primary ContactLuigi R Boccardi, BS
Backup ContactVaughn D Craddock, BS
Outcome results
None listed