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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
No intervention
Other interventionThere is no intervention
Treatment groups
Trial outcomes
Primary outcomes
Final diagnosis for hospitalization
Adjudicated diagnoses for hospitalization
Disease severity
Sequential Organ Failure Assesment (SOFA) score (minimum 0, maximum 24) collected during admission
Mortality
Mortality at day 30
Secondary outcomes
Length of stay
Both hospital and ICU stay
Mortality
Hospital, ICU, 28-day, 90-day and 1 year mortality
Post-sepsis sequelae
Up to 1 year post sepsis, e.g. decreased executive functions, weakness, fatigue etc.)
Readmissions
All cause readmissions in the first year after discharge
Other outcomes
Site of infection
Site of infection
Initiated therapies during admission
Initiated therapies during admission
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