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| Name | Class |
|---|---|
| Amsterdam UMC, location VUmc | OTHER |
| Flevoziekenhuis | OTHER |
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Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with infection | Patients with an (suspected) infection and a MEWS score 2 or higher |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | There is no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Both hospital and ICU stay | During hospitalization (up to day 180) |
| Mortality | Hospital, ICU, 28-day, 90-day and 1 year mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Site of infection | Site of infection | 4 years |
| Initiated therapies during admission | Initiated therapies during admission | 4 years |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oren Turgman, MD, MsC | Contact | 0205669111 | biosep@amsterdamumc.nl | |
| Evelien Reijnders, MD, MsC | Contact | 0205669111 | biosep@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Willem Joost Wiersinga, MD, PhD | Amsterdam UMC, location AMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flevoziekenhuis | Not yet recruiting | Almere Stad | Flevoland | 1315RA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40750284 | Derived | 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. |
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Blood samples (EDTA, heparin, PaxGene) and rectal swabs
| 5 years |
| Post-sepsis sequelae | Up to 1 year post sepsis, e.g. decreased executive functions, weakness, fatigue etc.) | Up to 1 year after sepsis episode |
| Readmissions | All cause readmissions in the first year after discharge | 5 years |
| Amsterdam UMC, location VUMC | Recruiting | Amsterdam | North Holland | 1081HZ | Netherlands |
|
| Amsterdam UMC, location AMC | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
|
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D001424 | Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D001423 | Bacterial Infections and Mycoses |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
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