Topic: Gastroenterology, Hepatology
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years 2. Patient has capacity and provided written informed consent for participation in the study prior to any study specific procedures 3. Cirrhosis defined either histologically on liver biopsy OR clinically by 2 of: 3.1. Imaging suggestive of cirrhosis (irregular outline and/or spleen >12cm) 3.2. Fibroscan >17.6kPa 3.3. Oesophageal or gastric varices or portal hypertensive gastropathy 3.4. Platelets <120 3.5. Ascites 3.6. Encephalopathy 4. Inpatient at Freeman Hospital, Newcastle or Royal Victoria Infirmary, Newcastle due to overt hepatic encephalopathy (OHE), treated with lactulose
Exclusion criteria
Exclusion criteria: 1. Age 80 2. Unable to provide informed consent 3. Unable to understand written English 4. Malignancy (including HCC) 5. Participating in another interventional study 6. Previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient acceptability; Timepoint(s): 8 weeks, 16 weeks, 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Admission rates; Timepoint(s): throughout study 2. Completion rate; Timepoint(s): throughout trial 3. Health related quality of life; Timepoint(s): 8 weeks, 16 weeks, 24 weeks 4. Healthcare resource utilisation; Timepoint(s): 8 weeks, 16 weeks 24 weeks 5. Rate of change of therapy; Timepoint(s): throughout study | — |
Countries
United Kingdom