Recruiting

Immune Dysfunction

Sponsor:

University of Minnesota

Code:

NCT07154615

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Observational Only

Study Details

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 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.

Conditions

Sepsis

Study ID

NCT07154615

Start date

Mar 1, 2026

Status verified date

Sep, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

ICU Patients with Sepsis

ICU Patients without Sepsis

Healthy Volunteers

Interventions

Observational Only

No intervention is included in this study

Primary outcome measure

  • EliSpot - Day 1 [ Time Frame: Day 1 ]
  • EliSpot - Day 4 [ Time Frame: Day 4 ]
  • EliSpot - Day 7 [ Time Frame: Day 7 ]
  • EliSpot - Day 14 [ Time Frame: Day 14 ]
  • EliSpot - Day 21 [ Time Frame: Day 21 ]
  • EliSpot - Day 28 [ Time Frame: Day 28 ]
  • Ex Vivo TNF Production - Day 1 [ Time Frame: Day 1 ]
  • Ex Vivo TNF Production - Day 4 [ Time Frame: Day 4 ]
  • Ex Vivo TNF Production - Day 7 [ Time Frame: Day 7 ]
  • Ex Vivo TNF Production - Day 14 [ Time Frame: Day 14 ]
  • Ex Vivo TNF Production - Day 21 [ Time Frame: Day 21 ]
  • Ex Vivo TNF Production - Day 28 [ Time Frame: Day 28 ]
  • Flow Cytometry of Peripheral Blood Leukocytes - Day 1 [ Time Frame: Day 1 ]
  • Flow Cytometry of Peripheral Blood Leukocytes - Day 4 [ Time Frame: Day 4 ]
  • Flow Cytometry of Peripheral Blood Leukocytes - Day 7 [ Time Frame: Day 7 ]
  • Flow Cytometry of Peripheral Blood Leukocytes - Day 14 [ Time Frame: Day 14 ]
  • Flow Cytometry of Peripheral Blood Leukocytes - Day 21 [ Time Frame: Day 21 ]
  • Flow Cytometry of Peripheral Blood Leukocytes - Day 28 [ Time Frame: Day 28 ]
  • Quantification of Cytokines in Serum - Day 1 [ Time Frame: Day 1 ]
  • Quantification of Cytokines in Serum - Day 4 [ Time Frame: Day 4 ]
  • Quantification of Cytokines in Serum - Day 7 [ Time Frame: Day 7 ]
  • Quantification of Cytokines in Serum - Day 14 [ Time Frame: Day 14 ]
  • Quantification of Cytokines in Serum - Day 21 [ Time Frame: Day 21 ]
  • Quantification of Cytokines in Serum - Day 28 [ Time Frame: Day 28 ]
  • Quantification of Chemokines in Serum - Day 1 [ Time Frame: Day 1 ]
  • Quantification of Chemokines in Serum - Day 4 [ Time Frame: Day 4 ]
  • Quantification of Chemokines in Serum - Day 7 [ Time Frame: Day 7 ]
  • Quantification of Chemokines in Serum - Day 14 [ Time Frame: Day 14 ]
  • Quantification of Chemokines in Serum - Day 21 [ Time Frame: Day 21 ]
  • Quantification of Chemokines in Serum - Day 28 [ Time Frame: Day 28 ]
  • Transcriptional Profiling - Day 1 [ Time Frame: Day 1 ]
  • Transcriptional Profiling - Day 4 [ Time Frame: Day 4 ]
  • Transcriptional Profiling - Day 7 [ Time Frame: Day 7 ]
  • Transcriptional Profiling - Day 14 [ Time Frame: Day 14 ]
  • Transcriptional Profiling - Day 21 [ Time Frame: Day 21 ]
  • Transcriptional Profiling - Day 28 [ Time Frame: Day 28 ]
  • CBC - Day 1 [ Time Frame: Day 1 ]
  • CBC - Day 4 [ Time Frame: Day 4 ]
  • CBC - Day 7 [ Time Frame: Day 7 ]
  • CBC - Day 14 [ Time Frame: Day 14 ]
  • CBC - Day 21 [ Time Frame: Day 21 ]
  • CBC - Day 28 [ Time Frame: Day 28 ]

Central Contacts and Locations

Central contacts

Mrunmayi Tilak

612-624-9990mtilak@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Kristine Kancans

kanca008@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.