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NCT03956043 Clinical Trial

Diagnostic Accuracy in Sepsis

Sepsis Syndrome Clinical Trial

Official title:
Diagnostic Accuracy of Clinical and Paraclinical Tools in Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03956043
Other study ID # Sepsis-OUH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2017
Est. completion date May 15, 2026

Study information
Verified date November 2023
Source Oslo University Hospital
Contact Aleksander R Holten, MD, PhD
Phone +47 99275784
Email aleksander.rygh.holten@ous-hf.no
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date May 15, 2026
Est. primary completion date September 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients >18 years old with suspected sepsis in the Emergency Department of Oslo University Hospital Oslo Exclusion Criteria: - Non

Study Design

Related Conditions & MeSH terms

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, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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