Hepatic EncephalopathyNCT04771104
The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis
A study testing Amino Acid Challenge (AAC) in people with Hepatic Encephalopathy and Liver Cirrhosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatic Encephalopathy, Liver Cirrhosis, Sleep Disturbance
- What is being tested?
- Amino Acid Challenge (AAC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2017to 22 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis
- Written informed consent
- >20 and <80 years of age
Who cannot join
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of gastroenterology and hepatology, Rigshospitalet
Copenhagen, 2100
About this study
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.
- Conditions
- Hepatic Encephalopathy, Liver Cirrhosis, Sleep Disturbance
- Being tested
- Amino Acid Challenge (AAC)
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid Challenge (AAC)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.
| Study group | Role | What they receive |
|---|---|---|
| Allocated to intervention at first experimental day | Active comparator | Not described Receives: Dietary Supplement: Amino Acid Challenge (AAC) |
| Allocated to intervention at second experimental day | Placebo comparator | Not described Receives: Dietary Supplement: Amino Acid Challenge (AAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the late post-illumination pupillary response after intervention compared to placebo
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Jan 2017
- Primary completion9 Jan 2018
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Nissen Bjerring, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771104
- Sponsor's protocol ID
- H15000210
- Status last verified
- Mar 2021
- First submitted
- 22 Feb 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36170326
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04771104
- Acronym / sponsor ID
- H15000210
- Conditions
- Hepatic Encephalopathy, Liver Cirrhosis, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allocated to intervention at first experimental day | Active comparator | Dietary Supplement: Amino Acid Challenge (AAC) |
| Allocated to intervention at second experimental day | Placebo comparator | Dietary Supplement: Amino Acid Challenge (AAC) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis
- Written informed consent
- >20 and <80 years of age
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Allocated to intervention at first experimental day, Allocated to intervention at second experimental day |
Primary outcome
Difference in the late post-illumination pupillary response after intervention compared to placebo
Time frame: 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Derived from this study: PubMed 36170326Kann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid Challenge (AAC) in people with Hepatic Encephalopathy and Liver Cirrhosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the late post-illumination pupillary response after intervention compared to placebo (time frame: 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.