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Enrolling by invitation NCT05433948

Diagnosing Minimal Hepatic Encephalopathy

— Observational Hepatic Encephalopathy Liver Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simultaneous EEG and CRT.
Who it may be relevant to
Registry conditions: Hepatic Encephalopathy, Liver Cirrhosis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Diagnostik Af Minimal Hepatisk Encephalopati: Association Mellem Kontinuert Reaktionsstidsmåling Og EEG-indices

Overview

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

Interventions

  • Diagnostic test Simultaneous EEG and CRT
    EEG is recorded with 32 electrodes and commercial recording equipment.10 min EEG is recorded in idle mode with eyes closed prior to continuous EEG recording during the CRT examination, see below. The test is performed via a laptop using EKHO software. The software generates 150 sound stimuli of 90 dB, which the patient hears in sound-insulated headphones. Via a push button in the dominant hand, the patient must respond as quickly as possible as soon as sounds are perceived. PSE test: Duration

Primary outcome measures

  • Concordant changes in reaction times and in EEG spectral and frequency analysis [Time frame: Up to 60 months]
  • Observation of cyclic activity in continous reaction times (CRT measures) [Time frame: Up to 60 months]
  • Change in EEG spectral and frequency analysis with a clinically indicated standard treatment for minimal hepatic encephalopathy [Time frame: Up to 60 months]

Eligibility criteria

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) -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Hospital of South West Jutland — Esbjerg

Identifiers

NCT: NCT05433948 · S-20180127

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗