NCT05787184: See'n'Run

Sepsis Early EvaluatioN Through Rapid Ultrasound and veNous Gas Analysis

Status unknown Last updated 28 March 2023

What this trial tests

trial in Sepsis in 400 participants. Status unknown.

Timeline

1 January 2023

Primary endpoint
1 January 2024

1 June 2024

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	400
Start date	1 January 2023
Primary completion	1 January 2024
Estimated completion	1 June 2024
Sites	1 location across Italy

Conditions studied

• Sepsis — all drugs for Sepsis →
• Septic Shock — all drugs for Septic Shock →
• Shock — all drugs for Shock →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, any sex, with Sepsis or Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.