Diagnostic Accuracy in Sepsis
Diagnostic Accuracy of Clinical and Paraclinical Tools in Sepsis
1 other identifier
observational
1,989
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2017
CompletedFirst Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedMarch 21, 2025
March 1, 2025
7.3 years
May 15, 2019
March 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- Patients \>18 years old with suspected sepsis in the Emergency Department of Oslo University Hospital Oslo
You may not qualify if:
- Non
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, Norway
Related 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: 10.1097/SHK.0000000000001981. Epub 2022 Sep 6.
PMID: 36130401DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aleksander R Holten, MD, PhD
Oslo University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 20, 2019
Study Start
May 15, 2017
Primary Completion
September 15, 2024
Study Completion
December 15, 2024
Last Updated
March 21, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share