Assessing Immune Dysfunction in Sepsis

University of Minnesota (UMN)

Status: Begins enrollment this month

Conditions: Sepsis

Treatments: Other: Observational Only

Study type: Observational

Funder types: Other

Identifiers

NCT07154615

URO-2025-34202

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

150 participants in 3 patient groups

ICU Patients with Sepsis

Treatment:

Other: Observational Only

ICU Patients without Sepsis

Treatment:

Other: Observational Only

Healthy Volunteers

Treatment:

Other: Observational Only