DIAGNOSis of Infection in Emergency Department

NCT03708796 | Completed

• 1 other identifier: AFERSAU-2018-01
• Study Type: observational
• Target: 759
• Locations: 1 country
• Sites: 7

Brief Summary

Septic pathology is an extremely frequent reason for consultation in our emergency services, with an annual incidence of severe forms between 50 to 95 cases per 100,000 inhabitants and a constant increase estimated at 9% per year. Diagnosing these patients early and precisely is a major challenge for the clinician, as this diagnosis will lead to more or less aggressive medical management. The criteria of S.I.R.S, used to define and to sort patients in sepsis according to the old definition, were completely abandoned in the last recommendations for lack of specificity but also of sensitivity. The latest recommendations suggest using another score, the "Quick Sepsis Related Organ Failure Assesment (qSOFA) score", in order to early detect septic patients at risk of poor progress. However, the recent literature highlights a very low sensitivity of the qSOFA score for the screening of septic patients, ranging from 30 to 60% according to the studies. In addition to qSOFA, other scores are described in the literature with apparently higher sensitivity, and thus seem more suitable for our daily practice. Among them is the NEWS score or the RETTS score. Each of these scores is again based upon the values of vital signs recorded as soon as the patient arrives in the emergency department. To date, very few studies have been interested, in a prospective way, in the sensitivity and the specificity of these different scores to diagnose the "infected" patients in the emergency departments. Therefore a non-interventional, prospective, multicenter cohort study is carried out here, in order to be able to compare, on the same cohort of patients admitted into emergency services, the diagnostic performance of these different scores with respect to the presence or absence of an infection. The aim of this study is to define the best clinical score to use in emergency medicine to quickly diagnose the infected patients, and offer them the best medical care.

Conditions

Sepsis; Septic Shock; Sepsis, Severe; Infection; Emergencies; Diagnosis

Keywords

ED; ER; qSOFA; SOFA; RETTS; NEWS; SIRS; triage

Outcome Measures

Primary Outcomes (5)

• Initial vital signs upon arrival at ED triage to evaluate the qSOFA score

  * Respiratory rate (movements per minute) * Systolic blood pressure (Hg mm) * Glasgow coma score (number from 0 to 15) will be assessed to evaluate the qSOFA score (number from 0 to 3)

  Timepoint 0 (ED triage)

• Initial vital signs upon arrival at ED triage to evaluate the NEWS score

  * Respiratory rate (movements per minute) * Pulsed SpO2 (%) with oxygen therapy (if applicable) and without oxygen therapy * Oxygen therapy (yes ou no) * Tympanic temperature (°C) * Systolic blood pressure (Hg mm) * Heart rate (beats per minute) * Glasgow coma score (number from 0 to 15) will be assessed to evaluate the NEWS score (number from 0 to 20)

  Timepoint 0 (ED triage)

• Initial vital signs upon arrival at ED triage to evaluate the RETTS score

  * Blocked airway or stridor (yes or no) * Respiratory rate (movements per minute) * Pulsed SpO2 (%) without oxygen therapy * Heart rate (beats per minute) * Level of conciousness (alert, accute disorientation, somnolence, Glasgow\<9) * Tympanic temperature (°C) will be assessed to evaluate the RETTS score (4 classes from "green" to "red")

  Timepoint 0 (ED triage)

• Initial vital signs upon arrival at ED triage and blood count to evaluate the SIRS score

  * Tympanic temperature (°C) * Heart rate (beats per minute) * Respiratory rate (movements per minute) * Leucocytemia (cells per mm³) will be assessed to evaluate the SIRS score (number from 0 to 4)

  Timepoint 0 (ED triage) and timepoint of blood sampling upon medical examination (average of 30 minutes after Timepoint 0)

• Antibiotic therapy instauration by the physician either during the emergency care managment or when leaving the emergency department (antibiotic therapy mentionned in the exit prescrition)

  The prescription of an antibiotic therapy will define the presence of an infection

  from patient arrival in the ED, to his leaving (from 1 hour to 24 hours)

Secondary Outcomes (2)

• Presence of a SOFA score value of 2 or greater

  from patient arrival in the ED, to his leaving (from 1 hour to 24 hours)

• Overall survival at Day 28

  Day 1 to Day 28 (from patient arrival in the ED, to the 28th day after)

Interventions

SIRS, qSOFA, NEWS, RETTS scores evaluation DIAGNOSTIC_TEST

Simple data collection from regular vital signs recordings during the initial phase of care management in the emergency department. Missing data is then possibly completed by the physician when made available during the regular medical management of the patient.

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 meeting the eligibility criteria from all participating investigational centers during the study period

You may qualify if:

• Patient of 18 years old or more
• Patients consulting in the emergency department
• Verbal agrement to participate

You may not qualify if:

• Patients consulting for an isolated traumatologic reason
• Patients under legal protection

Sponsors & Collaborators

• Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences: lead
• Collège de Médecine d'Urgence de la Région PACA (COPACAMU): collaborator

Study Sites (7)

Centre Hospitalier d'Antibes

Antibes, Alpes Maritimes, 06600, France

Location

Centre Hospitalier de Grasse

Grasse, Alpes Maritimes, 06130, France

Location

Centre Hospitalier Universitaire de Nice

Nice, Alpes Maritimes, 06001, France

Location

Hôpital de la Timone

Marseille, Bouches Du Rhône, 13005, France

Location

Hôpital Nord

Marseille, Bouches Du Rhône, 13005, France

Location

Hôpital Saint Anne

Toulon, Var, 83000, France

Location

Hôpital Sainte Musse

Toulon, Var, 83000, France

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; Infections; Emergencies; Disease

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: October 17, 2018
• Study Start: April 9, 2018
• Primary Completion: April 13, 2018
• Study Completion: September 1, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)