Function of Circulating Exosomes in Sepsis-induced Immunosuppression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sepsis Septic Shock Sepsis Syndrome Sepsis Bacterial Sepsis, Severe Sepsis Bacteremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No