NCT07154615 · University of Minnesota
Assessing Immune Dysfunction in Sepsis
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Observational Only
No intervention is included in this study
Primary outcome measures
EliSpot - Day 1
Time frame: Day 1
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
EliSpot - Day 4
Time frame: Day 4
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
EliSpot - Day 7
Time frame: Day 7
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
EliSpot - Day 14
Time frame: Day 14
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
EliSpot - Day 21
Time frame: Day 21
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
EliSpot - Day 28
Time frame: Day 28
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Transcriptional Profiling - Day 1
Time frame: Day 1
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Transcriptional Profiling - Day 4
Time frame: Day 4
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Transcriptional Profiling - Day 7
Time frame: Day 7
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Transcriptional Profiling - Day 14
Time frame: Day 14
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Transcriptional Profiling - Day 21
Time frame: Day 21
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Transcriptional Profiling - Day 28
Time frame: Day 28
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
CBC - Day 1
Time frame: Day 1
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
CBC - Day 4
Time frame: Day 4
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
CBC - Day 7
Time frame: Day 7
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
CBC - Day 14
Time frame: Day 14
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
CBC - Day 21
Time frame: Day 21
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
CBC - Day 28
Time frame: Day 28
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 <!-- -->
- 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:
- 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 \> 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
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2026 · Source of record for eligibility and locations