Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

Recruiting

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

• Registration Number: NCT06178822
• Lead Sponsor: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-10-25
• Study First Submitted: 2023-11-23
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease severity	During hospitalization (up to day 180)	Sequential Organ Failure Assesment (SOFA) score (minimum 0, maximum 24) collected during admission
Mortality	4 years	Mortality at day 30
Final diagnosis for hospitalization	4 years	Adjudicated diagnoses for hospitalization

Secondary Outcome Measures

Name	Time	Method
Length of stay	During hospitalization (up to day 180)	Both hospital and ICU stay
Post-sepsis sequelae	Up to 1 year after sepsis episode	Up to 1 year post sepsis, e.g. decreased executive functions, weakness, fatigue etc.)
Mortality	5 years	Hospital, ICU, 28-day, 90-day and 1 year mortality
Readmissions	5 years	All cause readmissions in the first year after discharge

Trial Locations

Locations (3)

Flevoziekenhuis; 🇳🇱 Almere, Flevoland, Netherlands

Amsterdam UMC, location VUMC; 🇳🇱 Amsterdam, North-Holland, Netherlands

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, North-Holland, Netherlands