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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT04771104

Collaborator

(none)

Enrollment

Location

Arms

12.7

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jan 9, 2018

Actual Study Completion Date :

Jan 22, 2018

Arms and Interventions

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.

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

Primary Outcome Measures

Difference in the late post-illumination pupillary response after intervention compared to placebo [12 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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).