Sepsis: From Syndrome to Personalized Care

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.

Study Overview

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

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 5 years.

• Study Type: Observational
• Enrollment (Estimated): 1950

Contacts and Locations

• Study Contact: Name: Aleksander R Holten, PhD; Phone Number: +4799275784; Email: aleksander.holten@gmail.com

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Aleksander R Holten, MD, PhD; Phone Number: +47 99275784; Email: aleksander.rygh.holten@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults with suspected sepsis or other severe conditions in the Emergency department.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of biomarkers in blood.	Explore how the concentration of biomarkers of inflammation change during the course of the disease.	One year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Exteranal validation of sepsis endotypes	Externally validate host response profiles and multi-omic sepsis endotypes in two international cohorts.	3 years
Temperal profile of host response	Describe how host response profiles develop in the days after hospital admission and initiation of treatment.	3 years
E. coli influences the host respons	Characterize how genetic variation within E. coli influences the host response to sepsis	3 years
Impact on microbiome	Impact from infection and antimicrobial treatment on gut and respiratory tract microbiome	At hospital admittance, day 3 and day 7.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Aleksander R Holten, PhD, Oslo University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: Sepsis-OUH-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No