How sepsis disrupts T cell and B cell immunity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

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  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 it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Thomas Griffith, PhD — University of Minnesota
• Study coordinator: Mrunmayi Tilak
• Email: mtilak@umn.edu
• Phone: 612-624-9990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Non-invasive hemodynamic guidance for sepsis care on medical wards

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.