Actively Recruiting
Assessing Immune Dysfunction in Sepsis
Led by University of Minnesota · Updated on 2026-03-19
150
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sepsis leads to sustained immune system dysfunction resulting in increased susceptibility to secondary infection while in the hospital or after discharge. Consequently, many of the \~2 million Americans that develop sepsis every year will end up back in the ICU, weeks and months later. The objective of this study is to define the cellular and molecular mechanisms driving the dysfunction and reprogramming of T cells and B cells that mediate cellular and humoral immunity using a combination of phenotypic, functional, genomic, and metabolomic assays.
CONDITIONS
Official Title
Assessing Immune Dysfunction in Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Presumed diagnosis of sepsis with life-threatening organ dysfunction caused by infection
- ICU patients meeting 2 or more quick SOFA criteria and organ dysfunction, including respiration rate ≥ 22 breaths/min or mechanical ventilation, altered mental status, low systolic blood pressure (<100 mm Hg) or use of inotropes, or acute SOFA score increase of ≥ 2 points due to infection
- ICU patients without sepsis requiring high acuity care
- Healthy volunteers aged 18 years or older with ASA status 1, 2, or 3, including some receiving outpatient dialysis
You will not qualify if you...
- Active cancer with chemotherapy or radiation treatment within the past 6 weeks
- Use of immunosuppressive drugs, biologic agents, cytokines, growth factors, or interleukins
- Steroid use over 300 mg hydrocortisone per day (equivalent to > 20 mg prednisone), excluding stress dose steroids after admission
- History or current autoimmune disease such as myasthenia gravis, Guillain Barré syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's granulomatosis, HIV/AIDS
- Active or history of acute or chronic lymphocytic leukemia
- Chronic hepatitis B infection not treated with nucleoside analogues before current hospitalization or HBV DNA > 100 IU/mL
- Hepatitis C infection currently under treatment or with detectable HCV RNA
- Participation in another investigational drug study within the past 4 weeks
- Current pregnancy
- Current incarceration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
K
Kristine Kancans
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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