SepsisBIOSEPNCT06178822
Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room
An observational study of Sepsis and Septic Shock, run by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) at 3 sites in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Sepsis, Severe
- How many people
- 3,300 participants
- Where
- 3 sitesNetherlands
- Study dates
- 25 Oct 2022to 1 Oct 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No informed consent given
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Not yet recruiting
Flevoziekenhuis
Almere Stad, Flevoland, 1315RA
Renee Douma, MD, PhD, 0368688888, biosep@amsterdamumc.nl
- Recruiting
Amsterdam UMC, location VUMC
Amsterdam, North Holland, 1081HZ
Prabath Nanayakkara, MD, PhD, 0204444444, biosep@amsterdamumc.nl
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105AZ
Willem Joost Wiersinga, MD, PhD, 0205669111, biosep@amsterdamumc.nl
About this study
Objectives:
- To compare the immune response of patients with or without sepsis presenting to the ED with a(n) (suspected) infection.
- 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.
- To determine the long term cognitive and physical sequelae of sepsis after admission.
Read the detailed description
Sepsis will be defined in accordance with the current Sepsis 3.0 criteria as a(n) (suspected) infection with evidence of organ failure, as reflected by a SOFA (Sequential Organ Failure Assessment) score of ≥2. Notably, a molecular definition of sepsis does not exist and there is no pathological gold standard; therefore, in accordance with the current international consensus, the investigators consider the commonly used clinical organ failure (SOFA) criteria as the best option. The SOFA score is composed of six organ dysfunctions (cardiovascular, pulmonary, renal, hepatic, coagulation and neurological). The SOFA score was developed for ICU patients, but its components can be easily scored in an ED (and hospital ward) setting with the exception of the pulmonary component; this pulmonary dysfunction score is based on the PaO2/FiO2 (PF) ratio, wherein PaO2 is the partial pressure of oxygen in arterial blood and FiO2 the fraction of inspired oxygen. Measurement of the PaO2 requires an arterial blood puncture, which is not routinely done on the ER or hospital ward. Therefore, the investigators will use an alternative method to determine the respiratory SOFA by determining the SpO2/FiO2 (SF) ratio, wherein SpO2 is peripheral oxygen saturation. SpO2 is routinely measured by finger pulse oximeter in patients with suspected infection; FiO2 is 21% when breathing room temperature and increases by 4% with each liter of oxygen provided per minute to a patient via a nasal cannula. Cut-off values for SF ratios correlating with SOFA pulmonary scores based on PF ratios have been validated in large data sets.
- Conditions
- Sepsis, Septic Shock, Sepsis, Severe, Infections, Infection Viral, Infection, Bacterial
- Being tested
- No intervention
- Keywords
- Biomarkers, Emergency Room, A&E, Accident & Emergency
- Medical subject headings
- Sepsis, Shock, Septic, Infections, Virus Diseases, Bacterial Infections, Respiratory Tract Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with infection | Patients with an (suspected) infection and a MEWS score 2 or higher Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final diagnosis for hospitalization
Adjudicated diagnoses for hospitalization
Measured: 4 years
Disease severity
Sequential Organ Failure Assesment (SOFA) score (minimum 0, maximum 24) collected during admission
Measured: During hospitalization (up to day 180)
Mortality
Mortality at day 30
Measured: 4 years
Secondary outcomes (4)
Length of stay
Both hospital and ICU stay
Measured: During hospitalization (up to day 180)
Mortality
Hospital, ICU, 28-day, 90-day and 1 year mortality
Measured: 5 years
Post-sepsis sequelae
Up to 1 year post sepsis, e.g. decreased executive functions, weakness, fatigue etc.)
Measured: Up to 1 year after sepsis episode
Readmissions
All cause readmissions in the first year after discharge
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start25 Oct 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Flevoziekenhuis
- Responsible party
- Principal investigator, W. J. Wiersinga, MD, Amsterdam UMC, location AMC
- Investigators
- Willem Joost Wiersinga, MD, PhD, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178822
- Sponsor's protocol ID
- BIOSEP
- Acronym
- BIOSEP
- Status last verified
- Feb 2025
- First submitted
- 23 Nov 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40750284
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room
- ClinicalTrials.gov ID
- NCT06178822
- Acronym / sponsor ID
- BIOSEP / BIOSEP
- Conditions
- Sepsis, Septic Shock, Sepsis, Severe, Infections, Infection Viral, Infection, Bacterial
- Keywords
- Biomarkers, Emergency Room, A&E, Accident & Emergency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Flevoziekenhuis
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- To compare the immune response of patients with or without sepsis presenting to the ED with a(n) (suspected) infection.
- 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.
- To determine the long term cognitive and physical sequelae of sepsis after admission.
Detailed description
Sepsis will be defined in accordance with the current Sepsis 3.0 criteria as a(n) (suspected) infection with evidence of organ failure, as reflected by a SOFA (Sequential Organ Failure Assessment) score of ≥2. Notably, a molecular definition of sepsis does not exist and there is no pathological gold standard; therefore, in accordance with the current international consensus, the investigators consider the commonly used clinical organ failure (SOFA) criteria as the best option. The SOFA score is composed of six organ dysfunctions (cardiovascular, pulmonary, renal, hepatic, coagulation and neurological). The SOFA score was developed for ICU patients, but its components can be easily scored in an ED (and hospital ward) setting with the exception of the pulmonary component; this pulmonary dysfunction score is based on the PaO2/FiO2 (PF) ratio, wherein PaO2 is the partial pressure of oxygen in arterial blood and FiO2 the fraction of inspired oxygen. Measurement of the PaO2 requires an arterial blood puncture, which is not routinely done on the ER or hospital ward. Therefore, the investigators will use an alternative method to determine the respiratory SOFA by determining the SpO2/FiO2 (SF) ratio, wherein SpO2 is peripheral oxygen saturation. SpO2 is routinely measured by finger pulse oximeter in patients with suspected infection; FiO2 is 21% when breathing room temperature and increases by 4% with each liter of oxygen provided per minute to a patient via a nasal cannula. Cut-off values for SF ratios correlating with SOFA pulmonary scores based on PF ratios have been validated in large data sets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with infection | – | Other: No interventionPatients with an (suspected) infection and a MEWS score 2 or higher |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No informed consent given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention | Other | Patients with infection |
Primary outcome
Final diagnosis for hospitalization
Time frame: 4 years
Adjudicated diagnoses for hospitalization
Disease severity
Time frame: During hospitalization (up to day 180)
Sequential Organ Failure Assesment (SOFA) score (minimum 0, maximum 24) collected during admission
Mortality
Time frame: 4 years
Mortality at day 30
4 secondary outcomes
Length of stay
Time frame: During hospitalization (up to day 180)
Mortality
Time frame: 5 years
Post-sepsis sequelae
Time frame: Up to 1 year after sepsis episode
Readmissions
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 40750284Reijnders 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Willem Joost Wiersinga, MD, PhD principal investigator
Amsterdam UMC, location AMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oren Turgman, MD, MsC (0205669111, biosep@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final diagnosis for hospitalization (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06178822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.