Function of Circulating Exosomes in Sepsis-induced Immunosuppression

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 Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Vaughn D Craddock, BS; Phone Number: 316-708-7352; Email: vcraddock2@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Vaughn D Craddock, BS; Phone Number: 316-708-7352; Email: vcraddock2@kumc.edu
      • Sub-Investigator: Leslie A Spikes, MD
      • Sub-Investigator: Navneet K Dhillon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adult patients admitted to the intensive care unit with sepsis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sepsis; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	All-cause mortality	From enrollment to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital mortality	All-cause mortality	From enrollment until hospital discharge, up to 90 days
90-day mortality	All-cause mortality	From enrollment to 90 days
Length of stay	Hospital length of stay	From enrollment until hospital discharge, up to 90 days
Duration of infection	Time to resolution of infection	From enrollment until resolution of SIRS, up to 90 days

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: University of Kansas
• Investigators: Principal Investigator: Nicholas S Britt, PharmD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2021
• Primary Completion (ANTICIPATED): October 31, 2021
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (ACTUAL): July 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Shock; Sepsis; Toxemia; Bacteremia; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: STUDY#00145638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No