Clinical trial NCT04203979: Sepsis: From Syndrome to Personalized Care
Official title: Sepsis: From Syndrome to Personalized Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis Syndrome
Sepsis
Sepsis, Severe
Septic Shock
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with suspected sepsis or other severe conditions in the Emergency department.

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 3 years.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of sepsis patient with elevated plasma-calprotectin
timeFrame: One year
measure: Area under the curve receiver operator characteristic (AUC - ROC) for inflammation biomarkers for detecting infection in critically ill patients.
timeFrame: One year
measure: Number of sepsis patient with bacterial DNA detected in blood by molecular biological tests.
timeFrame: One year
Secondary outcomes:
measure: Concentration of biomarkers in blood.
timeFrame: One year
Other outcomes:
measure: Sepsis endotypes
timeFrame: 3 years
measure: Exteranal validation of sepsis endotypes
timeFrame: 3 years
measure: Temperal profile of host response
timeFrame: 3 years
measure: E. coli influences the host respons
timeFrame: 3 years
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Aleksander R Holten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.