SepsisNCT07154615
Assessing Immune Dysfunction in Sepsis
An observational study of Sepsis, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Observational Only
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with and without sepsis in the ICU, compared to healthy volunteers
Who may be able to join
None listed.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Kristine Kancans, kanca008@umn.edu
About this study
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
- Being tested
- Observational Only
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational OnlyOther
No intervention is included in this study
| Study group | Role | What they receive |
|---|---|---|
| ICU Patients with Sepsis | Not described Receives: Other: Observational Only | |
| ICU Patients without Sepsis | Not described Receives: Other: Observational Only | |
| Healthy Volunteers | Not described Receives: Other: Observational Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
EliSpot - Day 1
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 1
EliSpot - Day 4
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 4
EliSpot - Day 7
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 7
EliSpot - Day 14
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 14
EliSpot - Day 21
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 21
EliSpot - Day 28
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 28
Ex Vivo TNF Production - Day 1
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 1
Ex Vivo TNF Production - Day 4
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 4
Ex Vivo TNF Production - Day 7
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 7
Ex Vivo TNF Production - Day 14
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 14
Ex Vivo TNF Production - Day 21
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 21
Ex Vivo TNF Production - Day 28
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 28
Transcriptional Profiling - Day 1
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 1
Transcriptional Profiling - Day 4
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 4
Transcriptional Profiling - Day 7
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 7
Transcriptional Profiling - Day 14
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 14
Transcriptional Profiling - Day 21
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 21
Transcriptional Profiling - Day 28
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 28
CBC - Day 1
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 1
CBC - Day 4
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 4
CBC - Day 7
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 7
CBC - Day 14
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 14
CBC - Day 21
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 21
CBC - Day 28
Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Mar 2026
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Griffith, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154615
- Sponsor's protocol ID
- URO-2025-34202
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Immune Dysfunction in Sepsis
- ClinicalTrials.gov ID
- NCT07154615
- Acronym / sponsor ID
- URO-2025-34202
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICU Patients with Sepsis | – | Other: Observational Only |
| ICU Patients without Sepsis | – | Other: Observational Only |
| Healthy Volunteers | – | Other: Observational Only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without sepsis in the ICU, compared to healthy volunteers
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational OnlyNo intervention is included in this study | Other | Healthy Volunteers, ICU Patients with Sepsis, ICU Patients without Sepsis |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Not yet recruiting
Personalized Metabolic Nutrition Sepsis Study
Pediatric Sepsis
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Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
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RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Griffith, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mrunmayi Tilak (612-624-9990, mtilak@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EliSpot - Day 1 (time frame: Day 1). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.