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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-01-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Encephalopathy Liver Cirrhosis Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Allocated to intervention at first experimental day

Group Type ACTIVE_COMPARATOR

Amino Acid Challenge (AAC)

Intervention Type DIETARY_SUPPLEMENT

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.

Allocated to intervention at second experimental day

Group Type PLACEBO_COMPARATOR

Amino Acid Challenge (AAC)

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No