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Sepsis: From Syndrome to Personalized Care

Sepsis: From Syndrome to Personalized Care

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04203979
Enrollment
1950
Registered
2019-12-18
Start date
2020-01-06
Completion date
2027-09-30
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Sepsis, Severe, Sepsis Syndrome, Septic Shock

Brief summary

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

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.

Interventions

None listed

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of sepsis patient with elevated plasma-calprotectinOne yearSensitivity of plasma-calprotectin for detecting infections in critical ill medical patients in the Emergency department.
Area under the curve receiver operator characteristic (AUC - ROC) for inflammation biomarkers for detecting infection in critically ill patients.One yearComparing 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.
Number of sepsis patient with bacterial DNA detected in blood by molecular biological tests.One yearThe 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).

Secondary

MeasureTime frameDescription
Concentration of biomarkers in blood.One yearExplore how the concentration of biomarkers of inflammation change during the course of the disease.

Countries

Norway

Contacts

CONTACTAleksander R Holten, PhD
aleksander.holten@gmail.com+4799275784
PRINCIPAL_INVESTIGATORAleksander R Holten, PhD

Oslo University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026