Sepsis Early EvaluatioN Through Rapid Ultrasound and veNous Gas Analysis

The investigators propose a multicenter, prospective, observational study which will take place between January 2023 until the pre-specified target number of 400 patients is reached, in any case within 1 year, in three major urban, teaching Hospitals. At the end of the enrolling phase, data analysis and conclusion of the study will occur within 6 months.

These patients will undergo a regular emergency room (ER) visit, during which a venous blood gas and a bedside ultrasound will be obtained, along with the collection of anamnestic and clinical parameters. All of these procedures normally take place in the first medical evaluation in the ER, therefore no unnecessary procedures or harm to patients will take place.

The data which will be obtained during the first medical visit include:

Anamnestic and demographic data:

• Age;
• Sex;
• History of hypertension, diabetes, congestive heart failure, chronic lung disease, chronic kidney failure, severe immunosuppression, cancer;
• Infective source, if known or suspected.

Vital parameters:

• Glasgow Coma Scale (GCS) and AVPU scale;
• Systolic, diastolic and mean arterial blood pressure;
• Heart and respiratory rate;
• Body temperature;
• Capillary refill time (CRT);
• Peripheral oxygen saturation and oxygen supplementation if present.

Venous blood gas analysis:

• pH;
• glucose;
• lactate;
• hemoglobin;
• sodium and potassium.

Bedside ultrasound examination:

• inferior vena cava distensibility through visual gestalt;
• global left ventricular contractility through visual gestalt;
• mitral annular plane systolic excursion (MAPSE), obtained through apical 4-chamber view.

All the above mentioned data will be obtained and reported in a specific module and subsequently added to the database.

Following the first medical visit, patients will prosecute their clinical course with diagnostic and therapeutic strategies as chosen by the attending emergency physicians. No additional maneuvers will take place as far as study procedures are concerned.

After a week from the enrollment, two physicians responsible for the study procedures (L.F. and G.T.) will manually extract clinical and laboratory data concerning the enrolled patients from the digital Health System softwares of the involved Hospitals. Data concerning death during hospital stay, ICU or regular ward admission, laboratory values, eventual positivity of blood culture, etc will be obtained and added to the study database.

The data which will be obtained at a week from enrollment are:

• Patient outcome: mortality, ICU or general ward admission;
• Results of blood cultures or other cultures from relevant specimens, if available;
• Results of blood tests performed during the first evaluation in the ER, including: white blood cell count (WBC), hematocrit, creatinine, C-reactive protein (CRP), Procalcitonin.

The last set of data concerning mortality will be obtained at 30 days, whether in-hospital (through the electronic hospital record) or out-of-hospital by telephone call.