Sepsis leaves immune system in Disarray—New study aims to find out why
NCT ID NCT07154615
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how sepsis causes lasting damage to the immune system, making people more likely to get serious infections later. Researchers will track 150 ICU patients with sepsis over 28 days, analyzing their blood cells and immune markers. The goal is to uncover the biological reasons behind this immune dysfunction, which could lead to better ways to prevent repeat hospitalizations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with and without sepsis in the ICU, compared to healthy volunteers
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can two blood markers catch sepsis before it turns deadly?
- Two cheap blood ratios put to the test as sepsis death predictors
- Can a computer model speed up sepsis blood tests?
- Stem cells put to the test against Sepsis's immune chaos
- Can the immune system reveal who will suffer kidney injury after sepsis?
- A routine calcium reading could reveal how sick a sepsis patient really is