Sepsis: From Syndrome to Personalized Care

Recruiting

• Conditions: Septic Shock; Sepsis Syndrome; Sepsis; Sepsis, Severe

• Registration Number: NCT04203979
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Study Start: 2020-01-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Primary Completion: 2024-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Concentration of biomarkers in blood.	One year	Explore how the concentration of biomarkers of inflammation change during the course of the disease.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway