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NCT Number: NCT07154615

Assessing Immune Dysfunction in Sepsis

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.

Recruiting

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Kristine Kancans

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational only

Other

No intervention is included in this study

Primary outcomes

  1. EliSpot - Day 1

    Time frame: Day 1

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  2. EliSpot - Day 4

    Time frame: Day 4

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  3. EliSpot - Day 7

    Time frame: Day 7

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  4. EliSpot - Day 14

    Time frame: Day 14

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  5. EliSpot - Day 21

    Time frame: Day 21

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  6. EliSpot - Day 28

    Time frame: Day 28

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  7. Ex Vivo TNF Production - Day 1

    Time frame: Day 1

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  8. Ex Vivo TNF Production - Day 4

    Time frame: Day 4

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  9. Ex Vivo TNF Production - Day 7

    Time frame: Day 7

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  10. Ex Vivo TNF Production - Day 14

    Time frame: Day 14

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  11. Ex Vivo TNF Production - Day 21

    Time frame: Day 21

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  12. Ex Vivo TNF Production - Day 28

    Time frame: Day 28

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  13. Flow Cytometry of Peripheral Blood Leukocytes - Day 1

    Time frame: Day 1

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  14. Flow Cytometry of Peripheral Blood Leukocytes - Day 4

    Time frame: Day 4

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  15. Flow Cytometry of Peripheral Blood Leukocytes - Day 7

    Time frame: Day 7

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  16. Flow Cytometry of Peripheral Blood Leukocytes - Day 14

    Time frame: Day 14

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  17. Flow Cytometry of Peripheral Blood Leukocytes - Day 21

    Time frame: Day 21

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  18. Flow Cytometry of Peripheral Blood Leukocytes - Day 28

    Time frame: Day 28

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  19. Quantification of Cytokines in Serum - Day 1

    Time frame: Day 1

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  20. Quantification of Cytokines in Serum - Day 4

    Time frame: Day 4

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  21. Quantification of Cytokines in Serum - Day 7

    Time frame: Day 7

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  22. Quantification of Cytokines in Serum - Day 14

    Time frame: Day 14

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  23. Quantification of Cytokines in Serum - Day 21

    Time frame: Day 21

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  24. Quantification of Cytokines in Serum - Day 28

    Time frame: Day 28

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  25. Quantification of Chemokines in Serum - Day 1

    Time frame: Day 1

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  26. Quantification of Chemokines in Serum - Day 4

    Time frame: Day 4

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  27. Quantification of Chemokines in Serum - Day 7

    Time frame: Day 7

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  28. Quantification of Chemokines in Serum - Day 14

    Time frame: Day 14

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  29. Quantification of Chemokines in Serum - Day 21

    Time frame: Day 21

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  30. Quantification of Chemokines in Serum - Day 28

    Time frame: Day 28

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  31. Transcriptional Profiling - Day 1

    Time frame: Day 1

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  32. Transcriptional Profiling - Day 4

    Time frame: Day 4

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  33. Transcriptional Profiling - Day 7

    Time frame: Day 7

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  34. Transcriptional Profiling - Day 14

    Time frame: Day 14

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  35. Transcriptional Profiling - Day 21

    Time frame: Day 21

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  36. Transcriptional Profiling - Day 28

    Time frame: Day 28

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  37. CBC - Day 1

    Time frame: Day 1

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  38. CBC - Day 4

    Time frame: Day 4

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  39. CBC - Day 7

    Time frame: Day 7

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  40. CBC - Day 14

    Time frame: Day 14

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  41. CBC - Day 21

    Time frame: Day 21

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

  42. CBC - Day 28

    Time frame: Day 28

    Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Kristine Kancans

CONTACT

[email protected]@umn.edu

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 4, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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