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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 1,950 is above the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Systemic Inflammatory Response Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adults with suspected sepsis or other severe conditions in the Emergency department.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Jan 2020 (actual). Primary completion is estimated for Jul 2027, 90 months after the start.
Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 90 months is above that.
Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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