Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room (BIOSEP)

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Status: Enrolling

Conditions: Sepsis, Severe; Infection Viral; Infections; Infections, Respiratory; Septic Shock; Infection, Bacterial; Sepsis

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06178822

BIOSEP

Details and patient eligibility

About

Objectives:

1. To compare the immune response of patients with or without sepsis presenting to the ED with a(n) (suspected) infection.
2. To determine immune response aberrations that are associated with an increased risk of developing sepsis in patients presenting to the ED with a(n) (suspected) infection without sepsis.
3. To determine the long term cognitive and physical sequelae of sepsis after admission.

Full description

Sepsis will be defined in accordance with the current Sepsis 3.0 criteria as a(n) (suspected) infection with evidence of organ failure, as reflected by a SOFA (Sequential Organ Failure Assessment) score of ≥2. Notably, a molecular definition of sepsis does not exist and there is no pathological gold standard; therefore, in accordance with the current international consensus, the investigators consider the commonly used clinical organ failure (SOFA) criteria as the best option. The SOFA score is composed of six organ dysfunctions (cardiovascular, pulmonary, renal, hepatic, coagulation and neurological). The SOFA score was developed for ICU patients, but its components can be easily scored in an ED (and hospital ward) setting with the exception of the pulmonary component; this pulmonary dysfunction score is based on the PaO2/FiO2 (PF) ratio, wherein PaO2 is the partial pressure of oxygen in arterial blood and FiO2 the fraction of inspired oxygen. Measurement of the PaO2 requires an arterial blood puncture, which is not routinely done on the ER or hospital ward. Therefore, the investigators will use an alternative method to determine the respiratory SOFA by determining the SpO2/FiO2 (SF) ratio, wherein SpO2 is peripheral oxygen saturation. SpO2 is routinely measured by finger pulse oximeter in patients with suspected infection; FiO2 is 21% when breathing room temperature and increases by 4% with each liter of oxygen provided per minute to a patient via a nasal cannula. Cut-off values for SF ratios correlating with SOFA pulmonary scores based on PF ratios have been validated in large data sets.

Enrollment: 3,300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or higher
• Presentation at the Emergency Department (ED)
• Clinical suspicion of infection or earlier confirmed infection
• Modified Early Warning Score (MEWS) of 2 or higher

Exclusion criteria

• No informed consent given

Trial design

3,300 participants in 1 patient group

Patients with infection

Description:

Patients with an (suspected) infection and a MEWS score 2 or higher

Treatment:

Other: No intervention