An observational study in Sepsis Syndrome, Sepsis and Sepsis, Severe, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Oslo University Hospital · Observational
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.
Adults with suspected sepsis or other severe conditions in the Emergency department.
Exclusion Criteria:
Number of sepsis patient with elevated plasma-calprotectin
Sensitivity of plasma-calprotectin for detecting infections in critical ill medical patients in the Emergency department.
Time frame: 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.
Time frame: 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).
Time frame: One year
Concentration of biomarkers in blood.
Explore how the concentration of biomarkers of inflammation change during the course of the disease.
Time frame: One year
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
Time frame: 3 years
Exteranal validation of sepsis endotypes
Externally validate host response profiles and multi-omic sepsis endotypes in two international cohorts.
Time frame: 3 years
Temperal profile of host response
Describe how host response profiles develop in the days after hospital admission and initiation of treatment.
Time frame: 3 years
E. coli influences the host respons
Characterize how genetic variation within E. coli influences the host response to sepsis
Time frame: 3 years
Impact on microbiome
Impact from infection and antimicrobial treatment on gut and respiratory tract microbiome
Time frame: At hospital admittance, day 3 and day 7.
Plan to share: Undecided
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Systemic Inflammatory Response Syndrome→
Oslo University Hospital