Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

Sepsis Clinical Trial

— BIOSEP  

Official title:

Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178822
• Other study ID #: BIOSEP
• Status: Recruiting
• Start date: October 25, 2022
• Est. completion date: October 1, 2026

Study information

• Verified date: December 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Oren Turgman, MD, MsC
• Phone: 0205669111
• Email: biosep[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3300
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Emergencies
• Infection Viral
• Infection, Bacterial
• Infections
• Infections, Respiratory
• Respiratory Tract Infections
• Sepsis
• Sepsis, Severe
• Septic Shock
• Toxemia
• Virus Diseases

Intervention

Other:
• No intervention
There is no intervention

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere	Flevoland
Netherlands	Amsterdam UMC, location AMC	Amsterdam	North-Holland
Netherlands	Amsterdam UMC, location VUMC	Amsterdam	North-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)	Amsterdam UMC, location VUmc, Flevoziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Site of infection	Site of infection	4 years
Other	Initiated therapies during admission	Initiated therapies during admission	4 years
Primary	Final diagnosis for hospitalization	Adjudicated diagnoses for hospitalization	4 years
Primary	Disease severity	Sequential Organ Failure Assesment (SOFA) score (minimum 0, maximum 24) collected during admission	During hospitalization (up to day 180)
Primary	Mortality	Mortality at day 30	4 years
Secondary	Length of stay	Both hospital and ICU stay	During hospitalization (up to day 180)
Secondary	Mortality	Hospital, ICU, 28-day, 90-day and 1 year mortality	5 years
Secondary	Post-sepsis sequelae	Up to 1 year post sepsis, e.g. decreased executive functions, weakness, fatigue etc.)	Up to 1 year after sepsis episode
Secondary	Readmissions	All cause readmissions in the first year after discharge	5 years