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NCT04771104 Clinical Trial

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

Liver Cirrhosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04771104
Other study ID # H15000210
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date January 22, 2018

Study information
Verified date March 2021
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date January 22, 2018
Est. primary completion date January 9, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Denmark Department of gastroenterology and hepatology, Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in the late post-illumination pupillary response after intervention compared to placebo 12 days
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