Sepsis Early EvaluatioN Through Rapid Ultrasound and veNous Gas Analysis

NCT05787184 | Unknown

• 1 other identifier: 4925
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is a life-threatening condition, caused by a systemic infection. It is particularly dangerous in already fragile populations and needs to be identified quickly to be treated as fast as possible, as discussed during the 2016 sepsis consensus and highlighted by the 2021 Surviving Sepsis Campaign. Yet, while there are scores to quickly identify patients who are at an increased risk of mortality (namely quick-SOFA, q-SOFA), these scores are also highly unspecific and cannot guarantee an adequate risk stratification. Therefore, it would be extremely valuable to further stratify mortality risk in patients who present to the emergency medical evaluation, especially those who present with stable hemodynamics but are at increased risk of decompensation during hospital stay. Furthermore, in the emergency room, it is sometimes impossible to re-evaluate patients regularly, thus, it would be important to immediately identify high-risk patients. Unfortunately, at the moment, there is no consensus. Through this study, the investigators will try to identify ultrasound parameters and biochemical markers which can be obtained during the first visit in the emergency room (ER) and that allow a quick risk stratification of patients with sepsis. The rationale of this study is to improve early identification of septic patients who are at risk of rapid deterioration in the course of their permanence in the ER and the hospital wards in general. The investigators selected a number of clinical, laboratory and bedside ultrasound parameters which have been previously shown to be correlated with mortality in sepsis, and will seek to identify which among these parameters best correlates with prognosis when acquired in the very first minutes of a patient's arrival in the ER. The objective would be to analyse these parameters and eventually to propose a new early sepsis score which might help the emergency physician to better tailor its efforts and clinical resources to the most sick patients.

Conditions

Sepsis; Septic Shock; Shock

Keywords

ultrasound; echography; POCUS; venous blood gas; emergency medicine

Outcome Measures

Primary Outcomes (1)

• Number of participants who are dead for any cause

  categorical variable

  7 days

Secondary Outcomes (4)

• Number of participants who die during the emergency department visit

  48 hours

• Number of participants who are dead for any cause

  30 days

• Number of patients who require ICU admission

  30 days

• Length of hospitalisation

  6 months

Eligibility Criteria

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

Study Population

All patients who are admitted to the ED with a clinical suspicion of sepsis and septic shock at the first medical visit.

You may qualify if:

• All adult, non pregnant patients admitted to the ED with a clinical suspicion of sepsis or septic shock

You may not qualify if:

• Age less than 18 years old
• Pregnancy

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario "A. Gemelli", IRCCS; Emergency Department

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic; Shock

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Maurizio Gabrielli, Dr.

CONTACT

06-30153150; maurizio.gabrielli@policlinicogemelli.it

Gianluca Tullo, Dr.

CONTACT

gianluca.tullo01@icatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Francesco Franceschi, Head of the Emergency Medicine Department

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 28, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)