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SepsisDIAGNOSEDNCT03708796

DIAGNOSis of Infection in Emergency Department

An observational study of Sepsis and Septic Shock, run by Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences at 7 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Septic Shock, Sepsis, Severe
What is being tested?
SIRS, qSOFA, NEWS, RETTS scores evaluation
How many people
759 participants
Where
7 sitesFrance
Study dates
9 Apr 2018to 1 Sep 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: -Patients meeting the eligibility criteria from all participating investigational centers during the study period

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites
  • Centre Hospitalier d'Antibes

    Antibes, Alpes Maritimes, 06600

  • Centre Hospitalier de Grasse

    Grasse, Alpes Maritimes, 06130

  • Hôpital de la Timone

    Marseille, Bouches Du Rhône, 13005

  • Hôpital Nord

    Marseille, Bouches Du Rhône, 13005

  • Centre Hospitalier Universitaire de Nice

    Nice, Alpes Maritimes, 06001

  • Hôpital Saint Anne

    Toulon, Var, 83000

  • Hôpital Sainte Musse

    Toulon, Var, 83000

Other trials in France

About this study

Official title: Comparison of the Performance Indicators (Sensitivity and Specificity) of qSOFA, SIRS, NEWS, and RETTS Scores, for Diagnosis of the Infected Patient at the Emergency Department Triage

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.

Read more

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.

Read the detailed description

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 with direct repercussions on the patient's morbidity and mortality.

The latest publications of March 2017 have completely changed the definition of the septic patient, in particular by eliminating the concept of "severe sepsis". Today the patient can be classified as either an "infected" or "sepsis" patient when there is associated organ failure, or as "septic shock" when it is necessary to use a cathecholaminergic support to maintain a sufficient blood pressure. There is a real nosological continuum between these three diagnostic entities and each of them is tainted by a growing intra-hospital mortality. One in ten patients will progress from infection to sepsis during their hospitalization and 3% of sepsis will progress to septic shock, making it easy to understand the value of screening these patients quickly in order to stop the progression of the infection. The triage of these patients, as soon as they arrive in an emergency service is therefore essential.

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. Indeed, a large number of non-septic patients presenting to the emergency department, has at least two SIRS criteria from the initial phase of their care, making it difficult to use this score as a reliable diagnostic tool.

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. This score is easily usable because it takes into account only three criteria that are: (i) the respiratory rate ≥ 22 / min, (ii) the systolic blood pressure ≤ 100 mmHg, (iii) and the level of vigilance of the patient to evaluate by the Glasgow score <15. Each criterion is weighted by 1 point if it is present. A score of qSOFA ≥2 is considered positive, and in this case the patient must be managed quickly with optimization of its volemia and implementation of a suitable antibiotic treatment within one hour.

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. Such sensitivity values seem insufficient to properly screen septic patients in an emergency department. Some authors even report similar AUCs for qSOFA and SIRS at 0.72 and 0.73, respectively, to screen for the severe septic patient, concluding that the decision to abandon SIRS for qSOFA may be a little premature.

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, such as the respiratory rate, the heart rate, the oxygen saturation, the temperature, the blood pressure or the level of patient's vigilance.

A prospective cohort study of 1535 patients in emergency departments have compared the RETTS score to the qSOFA score showing a much better sensitivity of the RETTS score with a value of 85% against only 32% for qSOFA, for the screening of patients with severe sepsis according to the "SEPSIS-2" definition.

A recent study published in April 2017, compared qSOFA, SIRS, and NEWS to predict mortality or hospitalizations into intensive care units for septic patients in emergencies. Once again the qSOFA score showed a low sensitivity at 54% versus 67% for a NEWS score ≥ 8.

To date, several studies have compared the prognostic contribution of these different scores and their ability to predict mortality or even hospitalization in intensive care units, but 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. Whereas this first step seems essential in order to implement the most appropriate therapeutic strategy, today, if we stick to the recommendations, the diagnosis of the infected patient is based solely on the physician clinical feeling.

Therefore it seemed interesting to carry out a prospective, multicenter cohort study, in order to be able to compare, on the same cohort of patients admitted into emergency services, the diagnostic performance of these different scores (qSOFA, SIRS, NEWS, and RETTS ) with respect to the presence or absence of an infection.

Being tested
SIRS, qSOFA, NEWS, RETTS scores evaluation
Keywords
ED, ER, qSOFA, SOFA, RETTS, NEWS, SIRS, triage
Medical subject headings
Sepsis, Shock, Septic, Infections, Emergencies, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIRS, qSOFA, NEWS, RETTS scores evaluationDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Timepoint 0 (ED triage)

  2. 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)

    Measured: Timepoint 0 (ED triage)

  3. 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")

    Measured: Timepoint 0 (ED triage)

  4. 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)

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

  5. 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

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

Secondary outcomes (2)
  1. Presence of a SOFA score value of 2 or greater

    The occurence of a SOFA score value of 2 or greater will define the presence of sepsis according to the last recommandations.

    Vital signs to be recorded for the SOFA score evaluation:

    • Thrombocytemia (10^9/L)
    • Bilirubinemia (µmol/l)
    • Creatininemia (µmol/l)
    • Glasgow coma score
    • Average blood pressure (Hg mm)
    • Cathecholamine usage
    • Pa02/FiO2 ratio

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

  2. Overall survival at Day 28

    Patient status will be collected in the patient file. Every patient leaving the hospital before Day 28 will be considered alive at Day 28.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2018
  2. Study start9 Apr 2018
  3. Primary completion13 Apr 2018
  4. Study completion1 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03708796
Sponsor's protocol ID
AFERSAU-2018-01
Acronym
DIAGNOSED
Status last verified
Oct 2018
First submitted
19 Apr 2018
Last updated
17 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Septic Shock, run by Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initial vital signs upon arrival at ED triage to evaluate the qSOFA score (time frame: Timepoint 0 (ED triage)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.

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