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:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT05733832
Eligibility Criteria:
Inclusion Criteria:
1. Male or female age ≥18
2. Diagnosis of advanced liver disease, defined as either (must meet either a or b)
1. cirrhosis based on (either i or ii):
* biopsy
* characteristic clinical, laboratory, and imaging findings
2. acute alcoholic hepatitis, defined by NIAAA Alcoholic Hepatitis Consortia, as
* onset of jaundice (serum bilirubin \>3.0 mg/dL) in prior 8 weeks
* consumption of \>40 (female) or 60 (male) g alcohol/day for ≥6 months, with \<60 days abstinence before jaundice onset,
* AST\>50 IU/L, AST/ALT\>1.5, and both values \<400 IU/L
* liver biopsy confirmation in patients with confounding factors
3. Has at least one of the following complications due to advanced liver disease occurring during hospitalization:
1. ascites requiring diuretics or paracentesis
2. hepatic encephalopathy requiring lactulose or rifaximin
3. gastrointestinal bleeding due to portal hypertension
4. jaundice
4. Has planned discharge alive to home or a facility within 72 hours of informed consent
5. Able and willing to provide informed consent
Exclusion Criteria:
1. discharge under hospice
2. listed for liver transplant with MELD-Na ≥ 35
3. unable or unwilling to participate in post-discharge follow-up either in-person or virtually
4. unable to speak or understand English and/or Spanish
5. low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments
6. lack of access to a telephone
7. incarcerated
8. concurrent enrollment in an interventional research study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05733832
Study Brief:
Protocol Section:
NCT05733832