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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT03634293
Eligibility Criteria:
* Inclusion Criteria:
* Subject is admitted to the ICU
* Subject has a clinical diagnosis of sepsis or septic shock
* Exclusion Criteria:
* Liver function tests (aspartate aminotransferase and Alanine transaminase) above three times the normal levels.
* Creatinine clearance levels below 30.
* Life expectancy below 28 days due to terminal illness.
* Moribund condition with life expectancy of less than 24 hours.
* Pregnancy or lactating women.
* Known hypersensitivity to the study drug.
* Grade IV peripheral edema at time of randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03634293
Study Brief:
Protocol Section:
NCT03634293