The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2018
CompletedFirst Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedMarch 16, 2021
March 1, 2021
1 year
February 22, 2021
March 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in the late post-illumination pupillary response after intervention compared to placebo
12 days
Study Arms (2)
Allocated to intervention at first experimental day
ACTIVE COMPARATORAllocated to intervention at second experimental day
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis
- Written informed consent
- \>20 and \<80 years of age
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of gastroenterology and hepatology, Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
Kann AE, Ba-Ali S, Seidelin JB, Larsen FS, Hamann S, Bjerring PN. The effect of induced hyperammonaemia on sleep and melanopsin-mediated pupillary light response in patients with liver cirrhosis: A single-blinded randomized crossover trial. PLoS One. 2022 Sep 28;17(9):e0275067. doi: 10.1371/journal.pone.0275067. eCollection 2022.
PMID: 36170326DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant hepatologist, associate professor
Study Record Dates
First Submitted
February 22, 2021
First Posted
February 25, 2021
Study Start
January 1, 2017
Primary Completion
January 9, 2018
Study Completion
January 22, 2018
Last Updated
March 16, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share