Status:
ENROLLING_BY_INVITATION
Diagnosing Minimal Hepatic Encephalopathy
Lead Sponsor:
Esbjerg Hospital - University Hospital of Southern Denmark
Collaborating Sponsors:
Regionshospitalet Silkeborg
Herlev Hospital
Conditions:
Hepatic Encephalopathy
Liver Cirrhosis
Eligibility:
All Genders
18-90 years
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria for patients with liver cirrhosis:
- Age\> 18
- Liver cirrhosis verified by biopsy or appropriate clinic and biochemistry as well as imaging.
- Written informed consent
- Speaks and understands Danish
- For the subgroup with liver cirrhosis and normal cognition:
- Normal result in PSE and CRT testing and clinical examination without evidence of HE
- For the subgroup with liver cirrhosis and minimal hepatic encephalopathy:
- 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:
- Abnormal PSE and CRT result and / or disoriented in time, place or own data and / or asterixis or other clinical symptoms of HE
- Ability to collaborate on the performance of CRT test, PSE test and EEG
- Inclusion criteria healthy:
- Liver healthy
- Age over 18 years
- Formal education ≤ 14 years
- Written informed consent
- Speaks and understands Danish
- Inclusion criteria for pre-cirrhosis liver disease:
- As for healthy controls plus:
- In our local outpatient clinic
- Proven pre-cirrhosis liver disease
- Exclusion Criteria:
- Organic brain disease (eg previous epilepsy, apoplexy, dementia)
- Hyponatraemia (Na \<124 mmol / L)
- Sepsis one week prior to tests.
- Heart failure (EC less than 30% or NYHA class III and IV)
- Severe chronic obstructive pulmonary disease (GOLD stage 3 and 4 ie FEV1 / FVC below 0.7 and FEV1 \<50% of expected value)
- Highly controllable diabetes (HbA1C\> 60 mmol / mol)
- Renal failure (eGFR below 60)
- Known neurological diseases (epilepsy, stroke, dementia)
- 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) -
Exclusion
Key Trial Info
Start Date :
December 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT05433948
Start Date
December 1 2019
End Date
December 1 2031
Last Update
December 2 2024
Active Locations (1)
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1
Hospital of South West Jutland
Esbjerg, Denmark, 6700