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NCT Number: NCT06178822

Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

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.

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

There is no intervention

Primary outcomes

  1. Final diagnosis for hospitalization

    Time frame: 4 years

    Adjudicated diagnoses for hospitalization

  2. Disease severity

    Time frame: During hospitalization (up to day 180)

    Sequential Organ Failure Assesment (SOFA) score (minimum 0, maximum 24) collected during admission

  3. Mortality

    Time frame: 4 years

    Mortality at day 30

Secondary outcomes

  1. Length of stay

    Time frame: During hospitalization (up to day 180)

    Both hospital and ICU stay

  2. Mortality

    Time frame: 5 years

    Hospital, ICU, 28-day, 90-day and 1 year mortality

  3. Post-sepsis sequelae

    Time frame: Up to 1 year after sepsis episode

    Up to 1 year post sepsis, e.g. decreased executive functions, weakness, fatigue etc.)

  4. Readmissions

    Time frame: 5 years

    All cause readmissions in the first year after discharge

Other outcomes

  1. Site of infection

    Time frame: 4 years

    Site of infection

  2. Initiated therapies during admission

    Time frame: 4 years

    Initiated therapies during admission

Study contacts

Contact information is provided by the study sponsor or research team.

Evelien Reijnders, MD, MsC

CONTACT

[email protected]

0205669111

Oren Turgman, MD, MsC

CONTACT

[email protected]

0205669111

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • Flevoziekenhuis

Registry information

Acronym: BIOSEP

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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