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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT00433368
Eligibility Criteria:
Inclusion Criteria:
* Cirrhosis, diagnosed on the basis of clinical findings, sonographic, and/or histologic basis,
* Patients \>14 years, with HE grades 1 to 4 according to West Haven Criteria,
* Hyperammonemia (fasting venous blood ammonia level \>60 µmol/l), and
* Patients with a single reversible precipitating factor of HE such as constipation, hypokalemia, urinary tract infection, respiratory tract infection, spontaneous bacterial peritonitis (SBP), dehydration, or none.
Exclusion Criteria:
* hepatocellular carcinoma,
* severe septicemia,
* active gastrointestinal bleeding,
* hepatorenal syndrome,
* acute superimposed liver injury,
* advanced cardiac or pulmonary disease and end stage renal failure,
* patients with minimal HE
* patients taking sedatives, antidepressants, or benzodiazepines and
* patients with chronic HE on metronidazole or lactulose prior to admission.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
65 Years
Study:
NCT00433368
Study Brief:
Protocol Section:
NCT00433368