Diagnostic Accuracy in Sepsis

Diagnostic Accuracy of Clinical and Paraclinical Tools in Sepsis

The sepsis syndrome has recently been more stringently defined as "a life-threatening organ dysfunction caused by a dysregulated host response to infection". Clinical and paraclinical tools are investigated for their ability to adequately recognize sepsis early.

Study Overview

• Status: Completed
• Conditions: Sepsis Syndrome

• Study Type: Observational
• Enrollment (Actual): 1989

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Oslo University Hospital is a secondary and tertiary Hospital in Norway's largest city Oslo. The Emergency Department treats about 30 000 patient per year, including approximately 500 with suspected sepsis.

Description

Inclusion Criteria:

• Patients >18 years old with suspected sepsis in the Emergency Department of Oslo University Hospital Oslo

Exclusion Criteria:

• Non

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with suspected sepsis in Emergency Department; Patients with suspected sepsis treated by the sepsis emergency team or the medical emergency team in the Emergency Department of Oslo University Hospital Oslo are included prospectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy in sepsis	Sensitivity, specificity, predictive values, AUC of clinical criteria of sepsis in the Emergency department, compared to post hoc assesment	within 90 days after inclusion
Prognostic accuracy in sepsis	Sensitivity, specificity, predictive values, AUC of clinical criteria of sepsis in the Emergency department, compared to in hospital, 30 and 90 days mortality	90 days after inclusion

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Aleksander R Holten, MD, 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): May 15, 2017
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Shock; Sepsis; Toxemia; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: Sepsis-OUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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