Clinical trial NCT05433948: Diagnosing Minimal Hepatic Encephalopathy
Official title: Diagnostik Af Minimal Hepatisk Encephalopati: Association Mellem Kontinuert Reaktionsstidsmåling Og EEG-indices
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatic Encephalopathy
Liver Cirrhosis
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Silkeborg
name: Herlev Hospital
name: Aalborg University Hospital
First posted: 2022-06-27
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See \*cohorts'.

Brief summary: Our purpose is to

1. Examine the correlation between MDF in a resting EEG, recorded just before the CRT test, and the variance in reaction times indicated by the CRT index
2. At simultaneous CRT and EEG recording, examine whether a change in EEG is seen immediately before an extended reaction time occurs (defined by the 75th percentile). This will shed light on a direct pathophysiological association between what is measured with EEG and CRT.
3. Investigate whether cyclicity can be detected in the continuous reaction times and if so, whether amplitude and wavelength in this cyclic activity are correlated to EEG parameters.
4. Examine whether a response to standard HE treatment can be detected with EEG in patients who are thought to suffer from it. As well as if baseline outcome predict future hepatic encephalopathy.
5. With a view to further validating our findings, investigators want to correlate results from EEG and CRT with the most internationally widespread psychometric test, the Portosystemic Encephalopathy test (PSE), which necessitates the establishment of Danish normal values. A secondary purpose of this study is therefore
6. To establish Danish normal values for the PSE test and the Animal Naming test in Danes


Eligibility criteria: Inclusion criteria for patients with liver cirrhosis:

1. Age\> 18
2. Liver cirrhosis verified by biopsy or appropriate clinic and biochemistry as well as imaging.
3. Written informed consent
4. Speaks and understands Danish

For the subgroup with liver cirrhosis and normal cognition:

1. Normal result in PSE and CRT testing and clinical examination without evidence of HE

   For the subgroup with liver cirrhosis and minimal hepatic encephalopathy:
2. Abnormal result in PSE and / or CRT test, but oriented in time, place and own data.

   For the subgroup with liver cirrhosis and HE grade 2, the following applies:
3. Abnormal PSE and CRT result and / or disoriented in time, place or own data and / or asterixis or other clinical symptoms of HE
4. Ability to collaborate on the performance of CRT test, PSE test and EEG

Inclusion criteria healthy:

1. Liver healthy
2. Age over 18 years
3. Formal education ≤ 14 years
4. Written informed consent
5. Speaks and understands Danish

Inclusion criteria for pre-cirrhosis liver disease:

As for healthy controls plus:

1. In our local outpatient clinic
2. Proven pre-cirrhosis liver disease

Exclusion Criteria:

1. Organic brain disease (eg previous epilepsy, apoplexy, dementia)
2. Hyponatraemia (Na \<124 mmol / L)
3. Sepsis one week prior to tests.
4. Heart failure (EC less than 30% or NYHA class III and IV)
5. Severe chronic obstructive pulmonary disease (GOLD stage 3 and 4 ie FEV1 / FVC below 0.7 and FEV1 \<50% of expected value)
6. Highly controllable diabetes (HbA1C\> 60 mmol / mol)
7. Renal failure (eGFR below 60)
8. Known neurological diseases (epilepsy, stroke, dementia)
9. Intake of coffee or alcohol 6 hours before tests and change of dose in psychoactive drugs within 6 days of the test (morphine, antipsychotics, antidepressants) -

Primary outcomes:
measure: Concordant changes in reaction times and in EEG spectral and frequency analysis
timeFrame: Up to 60 months
measure: Observation of cyclic activity in continous reaction times (CRT measures)
timeFrame: Up to 60 months
measure: Change in EEG spectral and frequency analysis with a clinically indicated standard treatment for minimal hepatic encephalopathy
timeFrame: Up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of South West Jutland
Study officials:
References: