Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

NCT06178822 | Recruiting DMC

• 1 other identifier: BIOSEP
• Study Type: observational
• Target: 3,300
• Locations: 1 country
• Sites: 3

Brief Summary

Objectives:

1. 1.To compare the immune response of patients with or without sepsis presenting to the ED with a(n) (suspected) infection.
2. 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. 3.To determine the long term cognitive and physical sequelae of sepsis after admission.

Conditions

Sepsis; Septic Shock; Sepsis, Severe; Infections; Infection Viral; Infection, Bacterial; Infections, Respiratory

Keywords

Biomarkers; Emergency Room; A&E; Accident & Emergency

Outcome Measures

Primary Outcomes (3)

• Final diagnosis for hospitalization

  Adjudicated diagnoses for hospitalization

  4 years

• Disease severity

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

  During hospitalization (up to day 180)

• Mortality

  Mortality at day 30

  4 years

Secondary Outcomes (4)

• Length of stay

  During hospitalization (up to day 180)

• Mortality

  5 years

• Post-sepsis sequelae

  Up to 1 year after sepsis episode

• Readmissions

  5 years

Other Outcomes (2)

• Site of infection

  4 years

• Initiated therapies during admission

  4 years

Study Arms (1)

Patients with infection

Patients with an (suspected) infection and a MEWS score 2 or higher

Other: No intervention

Interventions

No intervention OTHER

There is no intervention

Patients with infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research population will include adult patients that present to the ED of participating hospitals. In order to be eligible to participate in the BIOSEP study there must also be a clinical suspicion of an infection or a confirmed infection and MEWS of 2 or higher.

You may qualify if:

• 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

You may not qualify if:

• No informed consent given

Sponsors & Collaborators

• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC): lead
• Amsterdam UMC, location VUmc: collaborator
• Flevoziekenhuis: collaborator

Study Sites (3)

Flevoziekenhuis

Almere Stad, Flevoland, 1315RA, Netherlands

NOT YET RECRUITING

Amsterdam UMC, location VUMC

Amsterdam, North Holland, 1081HZ, Netherlands

RECRUITING

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related Publications (1)

• Reijnders E, Turgman O, Joosten SCM, Schinkel M, Slim MA, Douma RA, Moeniralam HS, Peters-Sengers H, van der Poll T, Wiersinga WJ. Towards novel BIOmarkers to diagnose SEPsis (BIOSEP) in the emergency room: a protocol for a multicentre, prospective cohort study. BMJ Open. 2025 Aug 1;15(7):e103138. doi: 10.1136/bmjopen-2025-103138.

  PMID: 40750284 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (EDTA, heparin, PaxGene) and rectal swabs

MeSH Terms

Conditions

Sepsis; Shock, Septic; Infections; Virus Diseases; Bacterial Infections; Respiratory Tract Infections; Emergencies

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Bacterial Infections and Mycoses; Respiratory Tract Diseases; Disease Attributes

Study Officials

• Willem Joost Wiersinga, MD, PhD

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oren Turgman, MD, MsC

CONTACT

0205669111; biosep@amsterdamumc.nl

Evelien Reijnders, MD, MsC

CONTACT

0205669111; biosep@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. W.J. Wiersinga, MD

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 21, 2023
• Study Start: October 25, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-02

Locations

NL (3)