Sepsis: From Syndrome to Personalized Care

Study Overview
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Brief Summary
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This is a prospective, observational study designed to examine the performance of biomarkers, molecular biological methods and other analysis in blood from patient with suspected sepsis in the Emergency department, as well as identidying novel sepsis endotypes. Around 1500 patients will be enrolled.

Detailed Description
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The study will prospectively include adult patients (>18 years) with suspected sepsis admitted to Oslo University Hospital, Ullevål (OUH-Ullevål). Patients admitted to the emergency department and managed by the medical rapid response team or the sepsis rapid response team are considered eligible for inclusion. Informed consent will be collected at the emergency department if possible, or within few days, by a clinical investigator or a study nurse. The investigators aim to include 1500 patients treated by the Sepsis Rapid Response Team or Medical Emergency team for possible sepsis. Patients classified to have had other conditions than sepsis in the post hoc assessment will be used as controls. The inclusion period will be 3 years.

Official Title
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Sepsis: From Syndrome to Personalized Care

Conditions
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Sepsis Syndrome, Sepsis, Sepsis, Severe, Septic Shock

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admitted to emergency department OUH, Ullevål. managed by the medical rapid response team or the sepsis rapid response team Exclusion Criteria: Not given informed consent by patient or next of kin (if patient is not able to)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sepsis patient with elevated plasma-calprotectin | Sensitivity of plasma-calprotectin for detecting infections in critical ill medical patients in the Emergency department. | One year | 
| Area under the curve receiver operator characteristic (AUC - ROC) for inflammation biomarkers for detecting infection in critically ill patients. | Comparing area under the curve receiver operator characteristic (AUC - ROC) for calprotectin, pro-calcitonin, CRP and other biomarkers for detecting infections in critically ill patients in the Emergency department. | One year | 
| Number of sepsis patient with bacterial DNA detected in blood by molecular biological tests. | The performance of rapid molecular biological tests for detecting bacterial DNA in full blood in critically ill medical patients, compared to current state-of-the art diagnostics (blood culture). | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of biomarkers in blood. | Explore how the concentration of biomarkers of inflammation change during the course of the disease. | One year |