Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT05273034
Eligibility Criteria:
Inclusion Criteria:
* ED adult patients, with suspected infection
* Free given Oral consent given by the patient or by the trustworthy person / family member / close relative or inclusion in case of emergency.
AND at least one of the following:
* Serum lactate \> 2.0 mmol/l
* Systolic blood pressure \< 90 mmHg
* Suspicion of sepsis as defined by the SEPSIS-3 International consensus: life threatening organ dysfunction identified by a SOFA score of 2 at least or a quick SOFA score of 2 at least (altered consciousness, systolic blood pressure \< 100 mmHg, respiratory rate \> 22)
* For French sites, free given Oral consent given by the patient or by the trustworthy person / family member / close relative or inclusion in case of emergency. According to the Biomedical Research Law 14/2007 in Spain, the emergency consent is not apply. The written patient consent is mandatory.
Exclusion Criteria:
* Patient living in assisted-living home or nursing home or palliative center
* Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
* Anticipated life expectancy \< 3 months or "do not resuscitate" order
* Known acute heart failure
* No social security
* Pregnancy and breastfeeding
* Prisoners
* Participation in another interventional trial (RIPH 1 et 2)
* Patients that presented inclusion criteria more than 3 hours before inclusion
* Patient in whom antibiotics or fluid resuscitation has been started before inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05273034
Study Brief:
Protocol Section:
NCT05273034