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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT03987893
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years.
* Patients with ACLF with presence of hepatic encephalopathy \> grade 2 as per WHC
Exclusion Criteria:
* Pregnant women or those who are suspected to be having acute fatty liver of pregnancy
* Malarial hepatopathy, enteric hepatitis, or ischemic hepatitis.
* Serum Na \<125 mEq/litre
* Gastrointestinal (GI) obstruction, ileus, or gastric retention
* Bowel perforation
* Toxic colitis or toxic megacolon
* Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam)
* Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy
* Uncontrolled infection with hemodynamic instability requiring vasopressors.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03987893
Study Brief:
Protocol Section:
NCT03987893