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

NCT04803942 | Unknown

• 1 other identifier: CHM-2020/S2/06
• Study Type: observational
• Target: 692
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

Sepsis; clinical intuition; emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare emergency physicians' clinical intuition versus qSOFA score for prediction of 72 hours mortality in patients with suspected infection

  72 hours after inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to one of the participating emergency departments with suspected infection

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Sepsis; Emergencies

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Christelle JADEAU

CONTACT

02 44 71 07 81; cjadeau@ch-lemans.fr

Adrien PICAUD

CONTACT

02 43 43 43 43; apicaud@ch-lemans.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: January 19, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

FR (1)