Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAmsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No informed consent given

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    There is no intervention

Treatment groups

3,300 Participants
are divided into 1 treatment group
Group A: Patients with infection1 intervention

Trial outcomes

Primary outcomes

1

Final diagnosis for hospitalization

Adjudicated diagnoses for hospitalization

Time frame
4 years
2

Disease severity

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

Time frame
During hospitalization (up to day 180)
3

Mortality

Mortality at day 30

Time frame
4 years

Secondary outcomes

1

Length of stay

Both hospital and ICU stay

Time frame
During hospitalization (up to day 180)
2

Mortality

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

Time frame
5 years
3

Post-sepsis sequelae

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

Time frame
Up to 1 year after sepsis episode
4

Readmissions

All cause readmissions in the first year after discharge

Time frame
5 years

Other outcomes

1

Site of infection

Site of infection

Time frame
4 years
2

Initiated therapies during admission

Initiated therapies during admission

Time frame
4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Amsterdam UMC, location AMC

Sponsor institution

Amsterdam UMC, location VUmc

Collaborator

Flevoziekenhuis

Collaborator