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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT05918705
Eligibility Criteria:
Inclusion Criteria:
1. Acceptance of one of patient's 1st degree relatives.
2. Age ≥ 18 and ≤ 65 years old of both sexes.
3. Sedated or unconscious patients and on invasive mechanical ventilation.
4. Patients diagnosed with sepsis associated encephalopathy (SAE);
Exclusion Criteria:
1. Ocular and/or optic nerve pathology; e.g., ocular trauma or surgery, previous ocular pathology as glaucoma or cataract, conjunctival or orbital edema, vitreous hemorrhage and optic nerve disease or injury.
2. Intracranial pathology; e.g., central nervous system (CNS) infection, cerebrovascular accident, cerebral hemorrhage, brain trauma or tumor, and any previous neurosurgical procedure.
3. Toxic or metabolic encephalopathy, e.g., alcohol toxicity, liver or kidney disease.
4. Serious co-morbidities that could affect life expectancy, e.g., hematopathy or cancer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05918705
Study Brief:
Protocol Section:
NCT05918705