Status:
COMPLETED
The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Hepatic Encephalopathy
Liver Cirrhosis
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
Sleep disturbances are common among patients with liver cirrhosis, but the reasons are not well understood. In this project the investigators evaluated whether an increase in blood ammonia in patients...
Eligibility Criteria
Inclusion
- Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis
- Written informed consent
- \>20 and \<80 years of age
Exclusion
- Misuse of alcohol in the preceding 6 months,
- Episodes of hepatic decompensation leading to in-patient admissions during the previous month
- History or clinical signs of overt HE or severe sleep-wake disturbances
- On anti-HE treatment (lactulose, rifaximin, Hepa-Merz, Generaid, Bramino)
- History of significant head injury
- Neurological/psychiatric comorbidity needing medical treatment
- Taking neuroactive medication/medication known to affect sleep
- Travel across more than two time zones in the preceding 3 months
- Shift work in the preceding 5 years
- Contraindications for arterial puncture (negative collateral circulation test, wrist infection or vascular abnormalities).
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04771104
Start Date
January 1 2017
End Date
January 22 2018
Last Update
March 16 2021
Active Locations (1)
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1
Department of gastroenterology and hepatology, Rigshospitalet
Copenhagen, Denmark, 2100