Assessing Immune Dysfunction in Sepsis

NCT07154615 | Recruiting

• 1 other identifier: URO-2025-34202
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (42)

• EliSpot - Day 1

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

  Day 1

• EliSpot - Day 4

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

  Day 4

• EliSpot - Day 7

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

  Day 7

• EliSpot - Day 14

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

  Day 14

• EliSpot - Day 21

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

  Day 21

• EliSpot - Day 28

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

  Day 28

• Ex Vivo TNF Production - Day 1

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

  Day 1

• Ex Vivo TNF Production - Day 4

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

  Day 4

• Ex Vivo TNF Production - Day 7

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

  Day 7

• Ex Vivo TNF Production - Day 14

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

  Day 14

• Ex Vivo TNF Production - Day 21

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

  Day 21

• Ex Vivo TNF Production - Day 28

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

  Day 28

• Flow Cytometry of Peripheral Blood Leukocytes - Day 1

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

  Day 1

• Flow Cytometry of Peripheral Blood Leukocytes - Day 4

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

  Day 4

• Flow Cytometry of Peripheral Blood Leukocytes - Day 7

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

  Day 7

• Flow Cytometry of Peripheral Blood Leukocytes - Day 14

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

  Day 14

• Flow Cytometry of Peripheral Blood Leukocytes - Day 21

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

  Day 21

• Flow Cytometry of Peripheral Blood Leukocytes - Day 28

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

  Day 28

• Quantification of Cytokines in Serum - Day 1

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

  Day 1

• Quantification of Cytokines in Serum - Day 4

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

  Day 4

• Quantification of Cytokines in Serum - Day 7

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

  Day 7

• Quantification of Cytokines in Serum - Day 14

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

  Day 14

• Quantification of Cytokines in Serum - Day 21

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

  Day 21

• Quantification of Cytokines in Serum - Day 28

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

  Day 28

• Quantification of Chemokines in Serum - Day 1

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

  Day 1

• Quantification of Chemokines in Serum - Day 4

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

  Day 4

• Quantification of Chemokines in Serum - Day 7

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

  Day 7

• Quantification of Chemokines in Serum - Day 14

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

  Day 14

• Quantification of Chemokines in Serum - Day 21

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

  Day 21

• Quantification of Chemokines in Serum - Day 28

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

  Day 28

• Transcriptional Profiling - Day 1

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

  Day 1

• Transcriptional Profiling - Day 4

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

  Day 4

• Transcriptional Profiling - Day 7

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

  Day 7

• Transcriptional Profiling - Day 14

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

  Day 14

• Transcriptional Profiling - Day 21

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

  Day 21

• Transcriptional Profiling - Day 28

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

  Day 28

• CBC - Day 1

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

  Day 1

• CBC - Day 4

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

  Day 4

• CBC - Day 7

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

  Day 7

• CBC - Day 14

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

  Day 14

• CBC - Day 21

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

  Day 21

• CBC - Day 28

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

  Day 28

Study Arms (3)

ICU Patients with Sepsis

Other: Observational Only

ICU Patients without Sepsis

Other: Observational Only

Healthy Volunteers

Other: Observational Only

Interventions

Observational Only OTHER

No intervention is included in this study

Healthy Volunteers; ICU Patients with Sepsis; ICU Patients without Sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with and without sepsis in the ICU, compared to healthy volunteers

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Griffith, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristine Kancans

CONTACT

kanca008@umn.edukanca008@umn.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)