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Function of Circulating Exosomes in Sepsis-induced Immunosuppression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04979767
Recruitment Status : Recruiting
First Posted : July 28, 2021
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
University of Kansas
Information provided by (Responsible Party):
Nicholas Britt, 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.

Condition or disease
Sepsis Septic Shock Sepsis Syndrome Sepsis Bacterial Sepsis, Severe Sepsis Bacteremia

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Function of Circulating Exosomes in Sepsis-induced Immunosuppression
Actual Study Start Date : April 15, 2021
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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



Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: From enrollment to 28 days ]
    All-cause mortality


Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: From enrollment until hospital discharge, up to 90 days ]
    All-cause mortality

  2. 90-day mortality [ Time Frame: From enrollment to 90 days ]
    All-cause mortality

  3. Length of stay [ Time Frame: From enrollment until hospital discharge, up to 90 days ]
    Hospital length of stay

  4. Duration of infection [ Time Frame: From enrollment until resolution of SIRS, up to 90 days ]
    Time to resolution of infection


Biospecimen Retention:   Samples Without DNA
Whole Blood, Plasma, PBMCs, Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized adult patients admitted to the intensive care unit with sepsis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04979767


Contacts
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Contact: Luigi R Boccardi, BS 913-588-4022 lboccardi@kumc.edu
Contact: Vaughn D Craddock, BS 316-708-7352 vcraddock2@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Luigi R Boccardi, BS    913-588-4022    lboccardi@kumc.edu   
Contact: Vaughn D Craddock, BS    316-708-7352    vcraddock2@kumc.edu   
Sub-Investigator: Leslie A Spikes, MD         
Sub-Investigator: Navneet K Dhillon, PhD         
Sponsors and Collaborators
University of Kansas Medical Center
University of Kansas
Investigators
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Principal Investigator: Nicholas S Britt, PharmD University of Kansas Medical Center
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Responsible Party: Nicholas Britt, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04979767    
Other Study ID Numbers: STUDY#00145638
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Bacteremia
Systemic Inflammatory Response Syndrome
Infections
Inflammation
Pathologic Processes
Shock
Bacterial Infections
Bacterial Infections and Mycoses