New Strategy to Predict Early Sepsis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of a New Strategy to Predict Early Sepsis

Conditions
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Sepsis

Intervention / Treatment
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* Other: Blood sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Presenting to the Emergency Department Attending physician suspects possible sepsis based on at least 2 sign of Systemic inflammatory response syndrome (SIRS) criteria and suspicion of infection Exclusion Criteria: Patient is terminal (death anticipated in 12 hours) Informed consent unobtainable if the subject survives to hospital discharge. Subjects who are unable to provide blood as a standard of care. Blood sample could not be taken within 24 hours of a physician's first contact with the patient.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected Sepsis Group<br>Participants suspected of potential to develop sepsis recruited at the emergency department. | Other: Blood sample collection<br>* A blood sample (1 tube) will be collected for the analysis of the CR signature.<br>|
| Surgical Group<br>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. | Other: Blood sample collection<br>* A blood sample (1 tube) will be collected for the analysis of the CR signature.<br>|
| Healthy Group<br>Healthy participants | Other: Blood sample collection<br>* A blood sample (1 tube) will be collected for the analysis of the CR signature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of illness | Measured by serial Sequential Organ Failure Assessment (SOFA) score monitoring | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |