Function of Circulating Exosomes in Sepsis-induced Immunosuppression
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2021
CompletedFirst Submitted
Initial submission to the registry
May 14, 2021
CompletedFirst Posted
Study publicly available on registry
July 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJuly 28, 2021
July 1, 2021
7 months
May 14, 2021
July 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
28-day mortality
All-cause mortality
From enrollment to 28 days
Secondary Outcomes (4)
Hospital mortality
From enrollment until hospital discharge, up to 90 days
90-day mortality
From enrollment to 90 days
Length of stay
From enrollment until hospital discharge, up to 90 days
Duration of infection
From enrollment until resolution of SIRS, up to 90 days
Study Arms (2)
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
Eligibility Criteria
Hospitalized adult patients admitted to the intensive care unit with sepsis
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansas Medical Centerlead
- University of Kansascollaborator
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Biospecimen
Whole Blood, Plasma, PBMCs, Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas S Britt, PharmD
University of Kansas Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 14, 2021
First Posted
July 28, 2021
Study Start
April 15, 2021
Primary Completion
October 31, 2021
Study Completion
June 30, 2022
Last Updated
July 28, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share