No intervention
OtherThere is no intervention
NCT Number: NCT06178822
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Flevoziekenhuis, Almere Stad, Flevoland, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
There is no intervention
Time frame: 4 years
Adjudicated diagnoses for hospitalization
Time frame: During hospitalization (up to day 180)
Sequential Organ Failure Assesment (SOFA) score (minimum 0, maximum 24) collected during admission
Time frame: 4 years
Mortality at day 30
Time frame: During hospitalization (up to day 180)
Both hospital and ICU stay
Time frame: 5 years
Hospital, ICU, 28-day, 90-day and 1 year mortality
Time frame: Up to 1 year after sepsis episode
Up to 1 year post sepsis, e.g. decreased executive functions, weakness, fatigue etc.)
Time frame: 5 years
All cause readmissions in the first year after discharge
Time frame: 4 years
Site of infection
Time frame: 4 years
Initiated therapies during admission
Contact information is provided by the study sponsor or research team.
Evelien Reijnders, MD, MsC
CONTACT
Oren Turgman, MD, MsC
CONTACT
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Other
Acronym: BIOSEP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03708796
Diagnosis, Disease
Antibes, Alpes Maritimes, France
View Trial DetailsNCT05969275
Infections, Inflammation
Ottawa, Ontario, Canada
View Trial DetailsNCT05950984
Adult Children, Antibiotic Resistant Infection
London, United Kingdom
View Trial DetailsNCT06156072
Diagnosis, Disease
View Trial Details