Sepsis: From Syndrome to Personalized Care
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis Syndrome
- Sponsor
- Oslo University Hospital
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Area under the curve receiver operator characteristic (AUC - ROC) for inflammation biomarkers for detecting infection in critically ill patients.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Aleksander Rygh Holten
Principal Investigator
Oslo University Hospital
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)
Outcomes
Primary Outcomes
Area under the curve receiver operator characteristic (AUC - ROC) for inflammation biomarkers for detecting infection in critically ill patients.
Time Frame: 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.
Time Frame: 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
Time Frame: One year
Sensitivity of plasma-calprotectin for detecting infections in critical ill medical patients in the Emergency department.
Secondary Outcomes
- Concentration of biomarkers in blood.(One year)