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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04771104
Recruitment Status : Completed
First Posted : February 25, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Peter Nissen Bjerring, Rigshospitalet, Denmark

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Liver Cirrhosis Sleep Disturbance Dietary Supplement: Amino Acid Challenge (AAC) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 9, 2018
Actual Study Completion Date : January 22, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Allocated to intervention at first experimental day Dietary Supplement: Amino 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.
Placebo Comparator: Allocated to intervention at second experimental day Dietary Supplement: Amino 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.


Outcome Measures
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Primary Outcome Measures :
  1. Difference in the late post-illumination pupillary response after intervention compared to placebo [ Time Frame: 12 days ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771104


Locations
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Denmark
Department of gastroenterology and hepatology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
More Information
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Responsible Party: Peter Nissen Bjerring, Consultant hepatologist, associate professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04771104    
Other Study ID Numbers: H15000210
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatic Encephalopathy
Brain Diseases
Dyssomnias
Parasomnias
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
 Central Nervous System Diseases
Nervous System Diseases
Sleep Wake Disorders
Mental Disorders
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases