Function of Circulating Exosomes in Sepsis-induced Immunosuppression

University of Kansas

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT04979767

STUDY#00145638

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Sepsis

Description:

I. ≥ 50 years with ≥ 2 chronic comorbidities II. Highly suspected bacterial infection based on clinical or radiologic evidence III. ≥ 2 systemic inflammatory response syndrome (SIRS) criteria IV. Actual/anticipated admission to intensive care unit (ICU) V. Anticipated length of hospital stay ≥ 5 days

Control

Description:

I. ≥ 50 years with ≥ 2 chronic comorbidities II. No suspected bacterial infection III. Actual/anticipated admission to intensive care unit (ICU) IV. Anticipated length of hospital stay ≥ 5 days