Sepsis: From Syndrome to Personalized Care
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
admitted to emergency department OUH, Ullevål.
managed by the medical rapid response team or the sepsis rapid response team
Disqualifiers
Not given informed consent by patient or next of kin (if patient is not able to)
Trial population
Adults with suspected sepsis or other severe conditions in the Emergency department.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 year2
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 year3
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 yearSecondary outcomes
1
Concentration of biomarkers in blood.
Explore how the concentration of biomarkers of inflammation change during the course of the disease.
Time frame
One yearOther outcomes
1
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 years2
Exteranal validation of sepsis endotypes
Externally validate host response profiles and multi-omic sepsis endotypes in two international cohorts.
Time frame
3 years3
Temperal profile of host response
Describe how host response profiles develop in the days after hospital admission and initiation of treatment.
Time frame
3 years4
E. coli influences the host respons
Characterize how genetic variation within E. coli influences the host response to sepsis
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov