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Understanding Immune Dysfunction in Sepsis

This study aims to understand why sepsis (a life-threatening response to infection) can weaken your immune system, making you more vulnerable to new infections. Researchers are observing patients aged 18 and older who are in the ICU with a presumed diagnosis of sepsis and meet specific criteria, such as a high breathing rate. The study will look at how your immune cells (T cells and B cells) are affected by sepsis by taking measurements on Day 1, Day 4, and Day 7. The goal is to learn more about the cellular and molecular changes that lead to long-term immune problems after sepsis.

Study design
This is an observational study involving 150 participants. It is not testing any new treatments, but rather observing patients with sepsis.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will have measurements taken on Day 1, Day 4, and Day 7.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07154615

Assessing Immune Dysfunction in Sepsis

Recruiting
Not specifiedAges 18+Observational
University of Minnesota
~150 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:Observational Only

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
EliSpot - Day 1
Measured over Day 1
+41 more outcomes measured

Conditions

Sepsis

Explore related trials

Septicemia

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Thomas Griffith, PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Kristine Kancans
[email protected]@umn.edu
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Age ≥ 18
Patients requiring care at a M Health Fairview ICU due to high acuity of illness and no other evidence of sepsis
Age greater or equal to 18
ASA status 1, 2 or 3
May include patients who are receiving dialysis in an outpatient setting

Exclusion

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 \> 300mg hydrocortisone per day (equivalent of \> 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 \> 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

What this trial measures

  • EliSpot - Day 1Day 1

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

  • EliSpot - Day 4Day 4

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

  • EliSpot - Day 7Day 7

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

  • EliSpot - Day 14Day 14

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

  • EliSpot - Day 21Day 21

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

  • EliSpot - Day 28Day 28

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

  • Ex Vivo TNF Production - Day 1Day 1

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

  • Ex Vivo TNF Production - Day 4Day 4

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

  • Ex Vivo TNF Production - Day 7Day 7

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

  • Ex Vivo TNF Production - Day 14Day 14

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

  • Ex Vivo TNF Production - Day 21Day 21

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

  • Ex Vivo TNF Production - Day 28Day 28

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

  • Flow Cytometry of Peripheral Blood Leukocytes - Day 1Day 1

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

  • Flow Cytometry of Peripheral Blood Leukocytes - Day 4Day 4

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

  • Flow Cytometry of Peripheral Blood Leukocytes - Day 7Day 7

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

  • Flow Cytometry of Peripheral Blood Leukocytes - Day 14Day 14

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

  • Flow Cytometry of Peripheral Blood Leukocytes - Day 21Day 21

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

  • Flow Cytometry of Peripheral Blood Leukocytes - Day 28Day 28

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

  • Quantification of Cytokines in Serum - Day 1Day 1

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

  • Quantification of Cytokines in Serum - Day 4Day 4

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

  • Quantification of Cytokines in Serum - Day 7Day 7

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

  • Quantification of Cytokines in Serum - Day 14Day 14

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

  • Quantification of Cytokines in Serum - Day 21Day 21

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

  • Quantification of Cytokines in Serum - Day 28Day 28

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

  • Quantification of Chemokines in Serum - Day 1Day 1

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

  • Quantification of Chemokines in Serum - Day 4Day 4

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

  • Quantification of Chemokines in Serum - Day 7Day 7

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

  • Quantification of Chemokines in Serum - Day 14Day 14

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

  • Quantification of Chemokines in Serum - Day 21Day 21

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

  • Quantification of Chemokines in Serum - Day 28Day 28

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

  • Transcriptional Profiling - Day 1Day 1

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

  • Transcriptional Profiling - Day 4Day 4

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

  • Transcriptional Profiling - Day 7Day 7

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

  • Transcriptional Profiling - Day 14Day 14

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

  • Transcriptional Profiling - Day 21Day 21

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

  • Transcriptional Profiling - Day 28Day 28

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

  • CBC - Day 1Day 1

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

  • CBC - Day 4Day 4

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

  • CBC - Day 7Day 7

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

  • CBC - Day 14Day 14

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

  • CBC - Day 21Day 21

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

  • CBC - Day 28Day 28

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