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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICU Patients with Sepsis |
| ||
| ICU Patients without Sepsis |
| ||
| Healthy Volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Only | Other | No intervention is included in this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| EliSpot - Day 1 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 1 |
| EliSpot - Day 4 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 4 |
| EliSpot - Day 7 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 7 |
| EliSpot - Day 14 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 14 |
| EliSpot - Day 21 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 21 |
| EliSpot - 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 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 1 |
| Ex Vivo TNF Production - Day 4 |
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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:
ICU Without Sepsis Inclusion Criteria:
Healthy Volunteer Inclusion Criteria
Exclusion Criteria (all groups):
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Patients with and without sepsis in the ICU, compared to healthy volunteers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristine Kancans | Contact | kanca008@umn.edukanca008@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Griffith, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes |
| Day 4 |
| Ex Vivo TNF Production - 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 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 14 |
| Ex Vivo TNF Production - 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 28 |
| Transcriptional Profiling - Day 1 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 1 |
| Transcriptional Profiling - Day 4 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 4 |
| Transcriptional Profiling - Day 7 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 7 |
| Transcriptional Profiling - Day 14 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 14 |
| Transcriptional Profiling - Day 21 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 21 |
| Transcriptional Profiling - Day 28 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 28 |
| CBC - Day 1 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 1 |
| CBC - Day 4 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 4 |
| CBC - Day 7 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 7 |
| CBC - Day 14 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 14 |
| CBC - Day 21 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 21 |
| CBC - Day 28 | Sample analysis to determine waxing and waning of Course of Sepsis parameters associated with clinical outcomes | Day 28 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |