Recruiting

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT04979767

Conditions

Sepsis

Septic Shock

Sepsis Syndrome

Sepsis Bacterial

Sepsis, Severe

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Sepsis

Septic Shock

Sepsis Syndrome

Sepsis Bacterial

Sepsis, Severe

Study ID

NCT04979767

Start date

Apr 15, 2021

Status verified date

Jul, 2021

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Oct 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • 28-day mortality [ Time Frame: From enrollment to 28 days ]

Central Contacts and Locations

Central contacts

Luigi R Boccardi, BS

913-588-4022lboccardi@kumc.edu

Vaughn D Craddock, BS

316-708-7352vcraddock2@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Luigi R Boccardi, BS

913-588-4022lboccardi@kumc.edu

Vaughn D Craddock, BS

316-708-7352vcraddock2@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Jul 28, 2021

Last verified

Jul, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2021-07-28.