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Search / Trial NCT05433948

Diagnosing Minimal Hepatic Encephalopathy

Launched by ESBJERG HOSPITAL - UNIVERSITY HOSPITAL OF SOUTHERN DENMARK · Jun 22, 2022

Trial Information

Current as of July 23, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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) -

About Esbjerg Hospital University Hospital Of Southern Denmark

Esbjerg Hospital, part of the University Hospital of Southern Denmark, is a leading clinical research institution dedicated to advancing healthcare through innovative research and comprehensive patient care. With a focus on multidisciplinary collaboration and state-of-the-art facilities, the hospital conducts a wide range of clinical trials aimed at improving treatment outcomes and enhancing patient quality of life. Its commitment to scientific excellence and ethical standards positions Esbjerg Hospital as a pivotal contributor to the advancement of medical knowledge and the development of new therapies in southern Denmark and beyond.

Locations

Esbjerg, , Denmark

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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