Diagnosis of Covert/Minimal Hepatic Encephalopathy by Means of Continuous Reaction Time Measurement
Liver Cirrhosis, Hepatic Encephalopathy
About this trial
This is an interventional diagnostic trial for Liver Cirrhosis focused on measuring quality of life
Eligibility Criteria
Inclusion Criteria:
For healthy volunteers:
- Age> 18 years
- Written informed consent
- Speak and understand Danish
For patients:
- Age > 18 years
- Liver cirrhosis confirmed by biopsy or appropriate clinic and biochemistry, and imaging.
- Written informed consent
- Speak and understand Danish
Exclusion Criteria (patients and control persons):
- Clinical manifest hepatic encephalopathy
- Consumption of psychoactive substances within 6 days of test
- Organic brain disease (i.e. prior stroke, dementia)
- Hypothyroidism
- Renal failure (creatinine> 150 mg / dL)
- Hyponatremia (Na <125 mmol / L)
- Sepsis or bleeding within one week prior to testing.
- Serious sleep disorders
- Current treatment with lactulose, rifaximin or BCAA
Sites / Locations
- Hospital of South West Jutland
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Anti cHE treatment arm
Placebo arm
Of 150 included patients aprox. 44 regardless of CRT and PSE test outcome will be offered to enter randomisation and 3 months follow up. Half of 44 patients will receive both lactulose, rifaximin and branched chain aminoacids (Bramino) the other half placebo.
The goal of this intervention is to investigate whether the CRT method can detect an expected treatment response after initiation of the 3 named drugs know to ameliorate HE symptoms including psychometric test results.