Clinical Intuition for PRedicting Evolution in Sepsis in the Emergency Department - CIPRES-ED Study

Sepsis Clinical Trial

— CIPRES-ED  

Official title:

Clinical Intuition for PRedicting Evolution in Sepsis in the Emergency Department - CIPRES-ED Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803942
• Other study ID #: CHM-2020/S2/06
• Status: Recruiting
• Start date: January 19, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2021
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: 02 44 71 07 81
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sepsis is a syndrome involving infection and an abnormal systemic inflammatory response in the infected organism, resulting in organ dysfunction and possibly death. It is a major cause of hospital mortality. A large proportion of sepsis diagnoses are made in emergency departments. Early diagnosis and appropriate treatment have been shown to reduce mortality from this disease.

In a context of limited resources, it is therefore important to be able to quickly stratify patients presenting to the emergency department with a suspected infection into those who require rapid and intensive management because they are at risk of developing sepsis and septic shock and those who can be managed conventionally The objective of this study is to compare the clinical intuition of emergency room physicians and nurses with the qSOFA score to predict the clinical course of patients presenting to the emergency room with potential sepsis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 692
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting to one of the participating emergency departments with suspected infection, defined as the presence of at least one of these parameters:

Temperature = 38°C ou < 36°C measured in the emergency room Chills (in the emergency room or on recent history)

• No objection to participation in the study

Exclusion Criteria:

• Minor patient (<18 years)

• Patient under guardianship or other protective measure

• Patient unable to understand research information

• Patient refusing the use of their data for research purposes

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Locations

Country	Name	City	State
France	Centre Hospitalier Du Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare emergency physicians' clinical intuition versus qSOFA score for prediction of 30-day mortality in patients with suspected infection	We compare the area under the ROC curve of each test (Emergency physicians' clinical intuition versus qSOFA score) to predict 30-day mortality in patients with suspected infection	1 month after inclusion
Secondary	Compare emergency physicians' clinical intuition versus qSOFA score for prediction of 72 hours mortality in patients with suspected infection	We compare the area under the ROC curve of each test (Emergency physicians' clinical intuition versus qSOFA score) to predict 72 hours mortality in patients with suspected infection	72 hours after inclusion