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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT03158493
Eligibility Criteria:
Inclusion Criteria:
* Suspected source of infection
* Presence of any of the following organ dysfunction
* Systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg or fall in systolic blood pressure\> 40 mmHg.
* Creatinine\> 2.0 mg / dl or diuresis less than 0.5 ml/kg/h in the last 2 hours OR
* Bilirubin\> 2mg/dl,
* Platelet count\<100,000,
* Lactate\> 2 mmol/dl (or above the reference value),
* Coagulopathy (RNI\> 1.5 or APTT\>60 sec),
* PaO2/FiO2 ratio \<300 or recent or increased O2 need to maintain SpO2\> 90
Exclusion Criteria:
* End of life care
* Previous sepsis episode in the same hospital admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT03158493
Study Brief:
Protocol Section:
NCT03158493