Sepsis: From Syndrome to Personalized Care

Sepsis Clinical Trial

Official title:

Sepsis: From Syndrome to Personalized Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04203979
• Other study ID #: Sepsis-OUH-2
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Sepsis
• Sepsis Syndrome
• Sepsis, Severe
• Septic Shock
• Syndrome
• Systemic Inflammatory Response Syndrome
• Toxemia

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