| NCT ID | NCT07154615 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2028-11-01 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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 setti