Actively Recruiting

Age: 18Years +
All Genders
ID06178822

Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

Led by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) · Updated on 2025-10-02

3300

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

A

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

Lead Sponsor

A

Amsterdam UMC, location VUmc

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying patients who come to the Emergency Department with a suspected infection to understand the differences in immune response between those who develop sepsis and those who do not. The study also aims to identify immune response changes linked to a higher risk of sepsis and to examine the long-term cognitive and physical effects after sepsis hospitalization. Sepsis is defined here using the Sepsis 3.0 criteria, which considers organ failure measured by the SOFA score, reflecting dysfunction in six organ systems. The study does not involve any treatment interventions but observes patients who present with suspected infection and have a Modified Early Warning Score (MEWS) of 2 or higher. Researchers will use routine clinical measurements, including an adapted method for assessing respiratory function through the SpO2/FiO2 ratio, to determine organ failure. The study will follow patients during hospitalization and for up to four years afterward to monitor outcomes. Participants will be assessed with clinical observations and scoring systems to diagnose sepsis, evaluate disease severity during hospital stay, and track mortality over four years. Additional outcomes include length of hospital stay, readmissions up to five years, and post-sepsis complications up to one year after the sepsis episode. Data collection will include these medical outcomes without any study drug or intervention, focusing on observational follow-up and long-term health status.

CONDITIONS

Brief Title

Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • No informed consent given

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - During hospitalization (up to 6 months)

Participants with suspected infection undergo assessments to confirm sepsis status using clinical criteria and organ failure scores.

Assessments during hospital stay as per routine care

Long-term Monitoring

Duration - Up to 5 years

Participants are followed for outcomes such as mortality, readmissions, and post-sepsis sequelae over several years.

Periodic follow-up assessments over years after hospitalization

Trial Site Locations

Total: 3 locations

1

Flevoziekenhuis

Almere Stad, Flevoland, Netherlands, 1315RA

Not Yet Recruiting

2

Amsterdam UMC, location VUMC

Amsterdam, North Holland, Netherlands, 1081HZ

Actively Recruiting

3

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands, 1105AZ

Actively Recruiting

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Research Team

O

Oren Turgman, MD, MsC

E

Evelien Reijnders, MD, MsC

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Towards novel BIOmarkers to diagnose SEPsis (BIOSEP) in the emergency room: a protocol for a multicentre, prospective cohort study.

Evelien Reijnders, Oren Turgman, Sebastiaan C M Joosten...

https://pubmed.ncbi.nlm.nih.gov/40750284