Early Identification of SEPsis SIGNs in Emergency Department

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

815 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-06

Study Completion Date

2022-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients, freshly admitted at ED, with a suspected or confirmed infection.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarkers for the Early Identification of Sepsis in the Emergency Department

NCT02707718

Sepsis

COMPLETED

Diagnostic Performance of a New Bio-marker During Bacterial Sepsis

NCT02721134

Sepsis

COMPLETED NA

Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

NCT06178822

Sepsis Septic Shock Sepsis, Severe +4 more

RECRUITING

CLEAR Sepsis Clinical Study

NCT03231956

Sepsis

UNKNOWN

Study on the Construction and Application of Early Warning Model of Sepsis in Critically Ill Patients

NCT06904001

Sepsis Sepsis and Septic Shock Infection

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sepsis is an important health issue with considerable socio-economic consequences. In 2017, the World Health Association made sepsis a global health priority, and has adopted a resolution to improve the prevention, diagnosis, and management of sepsis.

Over the last decade, a decrease in the mortality rate has been observed; in particular thanks to improved management, more appropriate intervention approaches in the Emergency Department (ED) and better recognition of organ failure. This statement is based on qSOFA and SOFA scores from the international Sepsis-3 definition. Sepsis-3 can help front-line clinicians detect severe patients with a higher risk of mortality but does not predict the clinical deterioration especially in patients without initial organ dysfunction. Furthermore, studies still demonstrate that 20% of patients with infection or uncomplicated sepsis experience disease worsening within 72 hours after ED admission.

Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment very difficult in particular on Emergency Department (ED) patients due to their infectious illness background and the frequent comorbidities.

Unfortunately, as of today, no biological marker has yet been validated to appropriately predict early deterioration in unselected patients admitted to the ED with acute infection, irrespective of their clinical presentation. Physiology of sepsis is complex and some underlying dysfunction could already exist in the early phase of sepsis before patients meet diagnostic criteria. Thus, patients may be clinically asymptomatic at the origin of organ failure. As a result, doubtful patients are often over-hospitalized while they could be treated at home, leading to overcrowding and extra costs for hospitals In these conditions, the main challenge of ED clinicians is differentiating mild infections from life-threatening ones in the heavy workload of ED environment. Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients freshly admitted at ED, whom blood samples will serve to validate candidate markers.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

All of the following criteria:

* Delay between ED presentation and inclusion must not exceed 12h
* Age 18 years or greater
* Acute infection suspected or confirmed
* That fulfills at least two of the following systemic inflammatory response syndrome (SIRS) criteria:

* Temperature \> 38°C (100.4°F) or \< 36°C (96.8°F)
* Heart rate \> 90 bpm
* Respiratory rate \> 20 cycles/min or PaCO2 \< 32 mmHg
* Leukocyte \> 12000/mm3 or \< 4000/mm3 or 10% bands
* With a delta SOFA \< 2 from baseline
* At Risk for deterioration defined as:

1. any patient that the emergency department physician has admitted or intends to admit as an inpatient\* to the hospital.
2. patients discharged home (outpatient\*\*) who are either i) \>65 years old or ii) diagnosed with pneumonia

Exclusion Criteria

* Unable to obtain a valid and written consent from a patient or their legally authorized representative in accordance with the local regulatory instances (this include in FR: Person not affiliated to a health insurance scheme, or not a beneficiary of such a scheme. Persons who are the subject of a legal protection order. Person with restricted freedom following a legal or administrative decision and a person admitted without their consent pursuant to Articles L.3212-1 and 3213-1, which are not included in Article L.1122-8 of the French Public Health Code.)
* Known pregnancy, in labor or breastfeeding
* Patients with isolated uncomplicated pharyngitis, sinusitis, or otitis media
* Infectious symptoms present for \> 5 days prior to presentation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No