How sepsis disrupts T cell and B cell immunity

Assessing Immune Dysfunction in Sepsis

This project will test whether specific changes in T and B cells explain lasting immune weakness in adults hospitalized with sepsis, compared with ICU patients without sepsis and healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Minnesota (Academic / other)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT07154615 on ClinicalTrials.gov

What this trial studies

This observational study will enroll adults with sepsis in the ICU, critically ill ICU patients without sepsis, and healthy volunteers to provide comparison samples. Researchers will collect blood samples during the ICU stay and after discharge and apply phenotypic, functional, genomic, and metabolomic assays to T and B cells. The study aims to define the cellular and molecular pathways driving immune dysfunction and reprogramming after sepsis. Results will be compared across groups to identify signatures associated with secondary infections and worse recovery.

Who should consider this trial

Good fit: Ideal participants are adults (age ≥18) treated at the University of Minnesota M Health Fairview ICU who meet sepsis criteria by qSOFA/SOFA, plus ICU patients without sepsis and healthy adult volunteers for comparison.

Not a fit: Patients seeking immediate therapeutic benefit, those under 18, or individuals who cannot attend the enrolling center or provide blood samples are unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify immune-cell signatures that predict risk of secondary infections and inform development of targeted therapies after sepsis.

How similar studies have performed: Previous research has documented post-sepsis immune suppression and identified some cellular markers, but comprehensive multi-omic profiling of T and B cell reprogramming in ICU patients remains relatively novel.

Eligibility criteria

ICU With Sepsis Inclusion Criteria:

* Age ≥ 18
* Presumed diagnosis of sepsis, defined as "patients with life-threatening organ dysfunction caused by a dysregulated host response to infection"
* Patients in the ICU who meet 2 or more of the quick SOFA (qSOFA) definition along with organ dysfunction:

  1. Respiration rate ≥ 22 breaths/min and/or mechanically ventilated
  2. An alteration in mental status
  3. Systolic blood pressure of less than 100 mm Hg and/or receiving inotropes to maintain blood pressure AND/OR

  <!-- -->

  1. An acute change in SOFA score ≥2 points, consequent to the infection (can assume SOFA score = 0 in patients with no pre-existing organ dysfunction)

ICU Without Sepsis Inclusion Criteria:

* Age ≥ 18
* Patients requiring care at a M Health Fairview ICU due to high acuity of illness and no other evidence of sepsis

Healthy Volunteer Inclusion Criteria

* Age greater or equal to 18
* ASA status 1, 2 or 3
* May include patients who are receiving dialysis in an outpatient setting

Exclusion Criteria (all groups):

* Active cancer with chemotherapy and/or radiation treatment within the past 6 weeks
* Medication usage that includes immunosuppressive drugs, biologic agents, cytokines, growth factor and interleukins
* Steroid medication usage of \&gt; 300mg hydrocortisone per day (equivalent of \&gt; 20mg prednisone). Patients with chronic steroid use will be excluded, however patients who have had stress dose steroids administered following admission will be included.
* Patients with a history of, or who currently have evidence of autoimmune disease, including but not limited to: myasthenia gravis, Guillain Barré syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's granulomatosis, HIV/AIDS, etc.
* Patients with active or a history of acute or chronic lymphocytic leukemia
* Known history of chronic hepatitis B (HBV) infection and not on treatment with HBV nucleoside analogues prior to the current hospitalization, or HBV DNA \&gt; 100 IU/mL
* Known history of infection with hepatitis C (HCV) and currently undergoing treatment for HCV infection or has detectable HCV RNA
* Participation in another investigational interventional drug study within the past 4 weeks
* Current pregnancy
* Current incarceration

Where this trial is running

Minneapolis, Minnesota

• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Thomas Griffith, PhD — University of Minnesota
• Study coordinator: Kristine Kancans

Conditions Sepsis