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/40750284Actively Recruiting
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
A
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Lead Sponsor
A
Amsterdam UMC, location VUmc
Collaborating Sponsor
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
Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
O
Oren Turgman, MD, MsC
E
Evelien Reijnders, MD, MsC
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Evelien Reijnders, Oren Turgman, Sebastiaan C M Joosten...
https://pubmed.ncbi.nlm.nih.gov/40750284