Function of Circulating Exosomes in Sepsis-induced Immunosuppression

• Conditions: Sepsis; Septic Shock; Sepsis Bacterial; Sepsis, Severe; Sepsis Bacteremia; Sepsis Syndrome

• Registration Number: NCT04979767
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-15
• Study First Submitted: 2021-05-14
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-16
• Last Update Submitted: 2021-07-16
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28
• Primary Completion: 2021-10-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day mortality	From enrollment to 28 days	All-cause mortality

Secondary Outcome Measures

Name	Time	Method
Duration of infection	From enrollment until resolution of SIRS, up to 90 days	Time to resolution of infection
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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States