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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04203979
Other study ID # Sepsis-OUH-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 6, 2020
Est. completion date December 31, 2026

Study information

Verified date November 2023
Source Oslo University Hospital
Contact Aleksander R Holten, PhD
Phone +4799275784
Email aleksander.holten@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date December 31, 2026
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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 3 years
Other Exteranal validation of sepsis endotypes Externally validate host response profiles and multi-omic sepsis endotypes in two international cohorts. 3 years
Other Temperal profile of host response Describe how host response profiles develop in the days after hospital admission and initiation of treatment. 3 years
Other E. coli influences the host respons Characterize how genetic variation within E. coli influences the host response to sepsis 3 years
Primary Number of sepsis patient with elevated plasma-calprotectin Sensitivity of plasma-calprotectin for detecting infections in critical ill medical patients in the Emergency department. One year
Primary 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. One year
Primary 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). One year
Secondary Concentration of biomarkers in blood. Explore how the concentration of biomarkers of inflammation change during the course of the disease. One year
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