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Status:

NOT_YET_RECRUITING

Assessing Immune Dysfunction in Sepsis

Lead Sponsor:

University of Minnesota

Conditions:

Sepsis

Eligibility:

All Genders

18+ years

Brief Summary

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 America...

Eligibility Criteria

Inclusion

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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2026

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 1 2028

    Estimated Enrollment :

    150 Patients enrolled

    Trial Details

    Trial ID

    NCT07154615

    Start Date

    March 1 2026

    End Date

    November 1 2028

    Last Update

    January 8 2026

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University of Minnesota

    Minneapolis, Minnesota, United States, 55455