Assessing Immune Dysfunction in Sepsis

March 16, 2026 updated by: University of Minnesota
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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
    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 > 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy Volunteers
Other: Observational Only
No intervention is included in this study
ICU Patients with Sepsis
Other: Observational Only
No intervention is included in this study
ICU Patients without Sepsis
Other: Observational Only
No intervention is included in this study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
EliSpot - Day 1
Time Frame: Day 1
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 1
EliSpot - Day 4
Time Frame: Day 4
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 4
EliSpot - Day 7
Time Frame: Day 7
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 7
EliSpot - Day 14
Time Frame: Day 14
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 14
EliSpot - Day 21
Time Frame: Day 21
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 21
EliSpot - Day 28
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Day 28
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 28
Transcriptional Profiling - Day 1
Time Frame: Day 1
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 1
Transcriptional Profiling - Day 4
Time Frame: Day 4
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 4
Transcriptional Profiling - Day 7
Time Frame: Day 7
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 7
Transcriptional Profiling - Day 14
Time Frame: Day 14
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 14
Transcriptional Profiling - Day 21
Time Frame: Day 21
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 21
Transcriptional Profiling - Day 28
Time Frame: Day 28
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 28
CBC - Day 1
Time Frame: Day 1
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 1
CBC - Day 4
Time Frame: Day 4
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 4
CBC - Day 7
Time Frame: Day 7
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 7
CBC - Day 14
Time Frame: Day 14
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 14
CBC - Day 21
Time Frame: Day 21
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 21
CBC - Day 28
Time Frame: Day 28
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Griffith, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • URO-2025-34202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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