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

Primary Purpose

Hepatic Encephalopathy, Liver Cirrhosis, Sleep Disturbance

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Amino Acid Challenge (AAC)

About this trial

This is an interventional basic science trial for Hepatic Encephalopathy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Department of gastroenterology and hepatology, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allocated to intervention at first experimental day

Allocated to intervention at second experimental day

Arm Description

Outcomes

Primary Outcome Measures

Difference in the late post-illumination pupillary response after intervention compared to placebo

Secondary Outcome Measures

Full Information

NCT ID

NCT04771104

First Posted

February 22, 2021

Last Updated

March 14, 2021

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT04771104

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

January 9, 2018 (Actual)

Study Completion Date

January 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Encephalopathy, Liver Cirrhosis, Sleep Disturbance

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allocated to intervention at first experimental day

Arm Type

Active Comparator

Arm Title

Allocated to intervention at second experimental day

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Amino Acid Challenge (AAC)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Difference in the late post-illumination pupillary response after intervention compared to placebo

Time Frame

12 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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).

Facility Information:

Facility Name

Department of gastroenterology and hepatology, Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36170326

Citation

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.

Results Reference

derived

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

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