Hepatic Encephalopathy, Liver Cirrhosis, Sleep Disturbance
Conditions
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 with cirrhosis had an impact on sleep quality and the function of retinal ganglion cells measured by pupillary response to blue light.
Interventions
DIETARY_SUPPLEMENTAmino Acid Challenge (AAC)
The AAC contains 54 g banana flavoured amino acid mixture added 200-300 mL of water. The AAC simulates the composition of haemoglobin in approximately 400 mL of blood.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis * Written informed consent * \>20 and \<80 years of age
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the late post-illumination pupillary response after intervention compared to placebo | 12 days |
Countries
Denmark
Outcome results
None listed