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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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This is an observational prospective multicentre study on patients attending the emergency department and suspected to have sepsis. Blood markers characteristic of a Cellular Reprogramming (CR) signature and predicting severe sepsis and organ failure will be measured and validated.
Sepsis is a life-threatening medical condition caused by an infection and the complex and dysfunctional way by which the human body attempts to deal with it. It can affect people of all ages, causing 18-30 million cases and 5-8 million deaths annually worldwide. However, early diagnosis of sepsis is challenging due to the diversity and overlap of symptoms with other disorders and the lack of an early and accurate diagnostic method. Hancock and colleagues defined a gene expression signature characteristic of biological changes occurring during sepsis, known as cellular reprogramming (CR) and reflecting a type of immune amnesia (inability to respond to bacterial signals). This signature was shown to predict the development of sepsis and organ failure at first clinical presentation in the emergency room, by examining patient blood samples taken during an initial pilot single-center study.
This project will validate and refine the CR signature and demonstrate reproducibility, specificity, and sensitivity in a larger multi-center study to enable a new strategy to predict Sepsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected Sepsis Group | Participants suspected of potential to develop sepsis recruited at the emergency department. |
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| Surgical Group | Participants undergoing non-emergency scheduled surgery, including ear/nose and throat cases, orthopaedic surgery of the major joints including hip, knee, ankle, shoulder, and wrist. |
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| Healthy Group | Healthy participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Other | A blood sample (1 tube) will be collected for the analysis of the CR signature. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of illness | Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sequential Organ Failure Assessment (SOFA) Score monitoring | The organs scored are respiratory, cardiovascular, neurologic, hematologic, renal, and liver. Each organ is scored as 0 (best) to 4 (worse) and the total score is the sum of each component. | 72 hours |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suspected of sepsis will be recruited at the emergency department of participating institutions.
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| Name | Affiliation | Role |
|---|---|---|
| Robert E Hancock, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas, M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| Westmead Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25685830 | Background | Pena OM, Hancock DG, Lyle NH, Linder A, Russell JA, Xia J, Fjell CD, Boyd JH, Hancock RE. An Endotoxin Tolerance Signature Predicts Sepsis and Organ Dysfunction at Initial Clinical Presentation. EBioMedicine. 2014 Nov 1;1(1):64-71. doi: 10.1016/j.ebiom.2014.10.003. |
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The RNA-Seq data will be uploaded to Geo database when the study is complete or upon publication and will be freely available to researchers.
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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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RNA samples obtained from whole blood.
28-day survival rate after admission to hospital |
| 28 days |
| ICU length of stay | Length of stay in the Intensive Care Unit | 28 days |
| Quick Sequential Organ Failure Assessment (SOFA) Score greater than 2 | Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring | 6 hours |
| Sydney |
| Australia |
| Vancouver General Hospital | Vancouver | Canada |
| Hospital Universitario Moncaleano Perdomo | Neiva | Colombia |
| University Medical Center Groningen | Groningen | Netherlands |
| D013568 |
| Pathological Conditions, Signs and Symptoms |