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The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis

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Rigshospitalet

Status

Completed

Conditions

Hepatic Encephalopathy
Liver Cirrhosis
Sleep Disturbance

Treatments

Dietary Supplement: Amino Acid Challenge (AAC)

Study type

Interventional

Funder types

Other

Identifiers

NCT04771104
H15000210

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

9 participants in 2 patient groups, including a placebo group

Allocated to intervention at first experimental day
Active Comparator group
Treatment:
Dietary Supplement: Amino Acid Challenge (AAC)
Allocated to intervention at second experimental day
Placebo Comparator group
Treatment:
Dietary Supplement: Amino Acid Challenge (AAC)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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