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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.
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 5 years.
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sepsis endotypes | Comprehensively characterize the host response to infection in patients presenting to the ED with sepsis and identify endotypes by unsupervised machine learning methods | 3 years |
| Exteranal validation of sepsis endotypes |
Inclusion Criteria:
Exclusion Criteria:
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Adults with suspected sepsis or other severe conditions in the Emergency department.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksander R Holten, PhD | Contact | +4799275784 | aleksander.holten@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Aleksander R Holten, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36130401 | Result | Christensen EE, Binde C, Leegaard M, Tonby K, Dyrhol-Riise AM, Kvale D, Amundsen EK, Holten AR. DIAGNOSTIC ACCURACY AND ADDED VALUE OF INFECTION BIOMARKERS IN PATIENTS WITH POSSIBLE SEPSIS IN THE EMERGENCY DEPARTMENT. Shock. 2022 Oct 1;58(4):251-259. doi: 10.1097/SHK.0000000000001981. Epub 2022 Sep 6. |
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| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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Samples will be collected, together with routine blood samples, from patients with suspected sepsis shortly after arrival at the Emergency department, before antibiotics are given. Calprotectin, CRP and leukocytes wil be analysed in the routine laboratory. Blood will be biobanked for other analyses
Externally validate host response profiles and multi-omic sepsis endotypes in two international cohorts.
| 3 years |
| Temperal profile of host response | Describe how host response profiles develop in the days after hospital admission and initiation of treatment. | 3 years |
| E. coli influences the host respons | Characterize how genetic variation within E. coli influences the host response to sepsis | 3 years |
| Impact on microbiome | Impact from infection and antimicrobial treatment on gut and respiratory tract microbiome | At hospital admittance, day 3 and day 7. |
| D007239 |
| Infections |