Function of Circulating Exosomes in Sepsis-induced Immunosuppression

Sepsis Clinical Trial

Official title:

Function of Circulating Exosomes in Sepsis-induced Immunosuppression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979767
• Other study ID #: STUDY#00145638
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2021
• Source: University of Kansas Medical Center
• Contact: Luigi R Boccardi, BS
• Phone: 913-588-4022
• Email: lboccardi[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Sepsis
• Sepsis Bacterial
• Sepsis Syndrome
• Sepsis, Severe
• Septic Shock
• Systemic Inflammatory Response Syndrome
• Toxemia

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	All-cause mortality	From enrollment to 28 days
Secondary	Hospital mortality	All-cause mortality	From enrollment until hospital discharge, up to 90 days
Secondary	90-day mortality	All-cause mortality	From enrollment to 90 days
Secondary	Length of stay	Hospital length of stay	From enrollment until hospital discharge, up to 90 days
Secondary	Duration of infection	Time to resolution of infection	From enrollment until resolution of SIRS, up to 90 days