Infection, Bacterial, Infections, Infections, Respiratory, Infection Viral, Sepsis, Sepsis, Severe, Septic Shock
Conditions
Keywords
Biomarkers, Emergency Room, A&E, Accident & Emergency
Brief 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 sepsis. 3. 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.
Interventions
OTHERNo intervention
There is no intervention
Sponsors
Amsterdam UMC, location VUmc
Flevoziekenhuis
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* No informed consent given
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease severity | During hospitalization (up to day 180) | Sequential Organ Failure Assesment (SOFA) score (minimum 0, maximum 24) collected during admission |
| Mortality | 4 years | Mortality at day 30 |
| Final diagnosis for hospitalization | 4 years | Adjudicated diagnoses for hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmissions | 5 years | All cause readmissions in the first year after discharge |
| Post-sepsis sequelae | Up to 1 year after sepsis episode | Up to 1 year post sepsis, e.g. decreased executive functions, weakness, fatigue etc.) |
| Length of stay | During hospitalization (up to day 180) | Both hospital and ICU stay |
| Mortality | 5 years | Hospital, ICU, 28-day, 90-day and 1 year mortality |
Other
| Measure | Time frame | Description |
|---|---|---|
| Site of infection | 4 years | Site of infection |
| Initiated therapies during admission | 4 years | Initiated therapies during admission |
Countries
Netherlands
Contacts
Primary ContactOren Turgman, MD, MsC
Backup ContactEvelien Reijnders, MD, MsC
Outcome results
None listed