Liver CirrhosisNCT01773538
Diagnosis of Covert/Minimal Hepatic Encephalopathy by Means of Continuous Reaction Time Measurement
A study testing Lactulose and rifaximin and Branched Chain amino acids in people with Liver Cirrhosis and Hepatic Encephalopathy, run by Mette Munk Lauridsen at 2 sites in Denmark.
Trial summary
The investigators wish to investigate how the Continuous Reaction Time (CRT) method can be used in the diagnosis and monitoring of covert hepatic encephalopathy (cHE)in patients with cirrhosis of the liver. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis, Hepatic Encephalopathy
- What is being tested?
- Lactulose and rifaximin and Branched Chain amino acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2013to Nov 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For healthy volunteers:
- Age> 18 years
- Written informed consent
- Speak and understand Danish
- For patients:
- Age > 18 years
Show all 9Show fewer
- Liver cirrhosis confirmed by biopsy or appropriate clinic and biochemistry, and imaging.
- Written informed consent
- Speak and understand Danish
Who cannot join
- Clinical manifest hepatic encephalopathy
- Consumption of psychoactive substances within 6 days of test
- Organic brain disease (i.e. prior stroke, dementia)
- Hypothyroidism
- Renal failure (creatinine> 150 mg / dL)
- Hyponatremia (Na <125 mmol / L)
Show all 9Show fewer
- Sepsis or bleeding within one week prior to testing.
- Serious sleep disorders
- Current treatment with lactulose, rifaximin or BCAA
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hospital of South West Jutland
Esbjerg, 6700
Odense University Hospital
Odense, 5000
About this study
The investigators wish to investigate how the Continuous Reaction Time (CRT) method can be used in the diagnosis and monitoring of covert hepatic encephalopathy (cHE)in patients with cirrhosis of the liver. The hypothesis is that the CRT method (duration 10-2 minutes) can serve as a tool in the diagnosis and monitoring of cHE and is an alternative to using the Portosystemic Encephalopathy Test (PSE)(duration 20-25 minutes).
Read the detailed description
Objective: The aim of this project is to investigate whether continuous reaction time measurements (CRT) are suitable as a screening and monitoring tool for covert hepatic encephalopathy (c/mHE).
Method:
Sub-protocol 1: As a part of this PhD protocol 100 healthy individuals and 50 with chronic disease (not liver cirrhosis) will be tested using the CRT and PSE tests. This is to determine the normal range for the PSE test in the Danish population.
Sub-protocol 2: A total of 120 (aprox. 145 to adjust for drop outs) patients with liver cirrhosis from two Danish hospitals will be examined with both CRT and with the test that is the closest we get to a gold standard, namely portosystemic encephalopathy test (PSE). We wish to examine if the CRT test agrees with the PSE test, which may be to time consuming to perform in everyday clinical practice, and with quality of life scores (SF-36 and Sickness Impact Profile). The relationship between the CRT and PSE test and various blood tests and the Charlston co-morbidity score will also be examined.
Sub-protocol 3: Forty-four of the 120 included patients will, regardless of CRT test result, be randomized to treatment with lactulose, rifaximin and branched chain amino acids (BCAA) or placebo lactulose, rifaximin and BCAA. This is to evaluate whether the CRT method is able to detect a response to treatment, and see if changes in psychometric tests (PSE and CRT) are in accordance with quality of life scores and predicts subsequent development of overt hepatic encephalopathy.
Perspective: CRT method should, if it proves good enough, continue to be the Danish test of choice and hopefully be more widely used in our country. The validation of tests for the diagnosis of covert hepatic encephalopathy will give cirrhotic patients with covert hepatic encephalopathy and reduced quality of life the best opportunity to be diagnosed and offered appropriate treatment. If the CRT method is not able to identify a population that benefits from anti-encephalopathy treatment other screening and monitoring tests should be used.
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy
- Being tested
- Lactulose and rifaximin, Branched Chain amino acids, Placebo
- Keywords
- quality of life
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactulose and rifaximinDrug
3 months treatment. lactulose 25 Ml x3 per day. Rifaximin (550 mg) x 2 per day.
Branched Chain amino acidsDietary supplement
30 grams of branched chain amino acids (Bramino) per day is given to the patients in the antiHE treatment arm along with lactulose and rifaximin.
PlaceboOther
Patients in the placebo-arm receives both placebo-Bramino, placebo-lactulose and placebo-rifaximin.
| Study group | Role | What they receive |
|---|---|---|
| Anti cHE treatment arm | Active comparator | Of 150 included patients aprox. 44 regardless of CRT and PSE test outcome will be offered to enter randomisation and 3 months follow up. Half of 44 patients will receive both lactulose, rifaximin and branched chain aminoacids (Bramino) the other half placebo. Receives: Drug: Lactulose and rifaximin; Dietary Supplement: Branched Chain amino acids |
| Placebo arm | Placebo comparator | The goal of this intervention is to investigate whether the CRT method can detect an expected treatment response after initiation of the 3 named drugs know to ameliorate HE symptoms including psychometric test results. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Continuous Reaction Time Method versus Portosystemic Encephalopathy Test
The investigators are evaluating if the CRT and PSE test are in accordance at inclusion and after 3 months of treatment.
Measured: baseline and 3 months
Secondary outcomes (3)
Change in Continuous Reaction Time Method versus Quality of Life (QoL)
The results from both CRT and PSE test will be compared to the out come of the SF-36 and the SIP (Sickness impact profile) QoL measurements.
Measured: baseline and 3 months
Correlation between CRT test and PSE test at inclusion
The investigators wish to evaluate the correlation between the CRT and the PSE test at base line.
Measured: at baseline
Correlation between psychometric test results and quality of life af base line
The investigators wish to evaluate the correlation between the psychometric test results (CRT test result and PSE test result) and quality of life. The scientific question is which test correlates best to QoL.
Measured: at base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mette Munk Lauridsen
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, Odense University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark
- Responsible party
- Sponsor-investigator, Mette Munk Lauridsen, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Ove Schaffalitzky de Muckadell, Professor, Study director, Odense University HospitalJeppe Gram, PhD, MD, Study chair, Esbjerg Hospital - University Hospital of Southern DenmarkHendrik Vilstrup, Professor, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773538
- Sponsor's protocol ID
- CHECRT
- Status last verified
- Feb 2016
- First submitted
- 7 Jan 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Covert/Minimal Hepatic Encephalopathy by Means of Continuous Reaction Time Measurement
- ClinicalTrials.gov ID
- NCT01773538
- Acronym / sponsor ID
- CHECRT
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy
- Keywords
- quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Mette Munk LauridsenUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, Odense University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- Jan 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Jan 2013 (estimated)
- 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.
The investigators wish to investigate how the Continuous Reaction Time (CRT) method can be used in the diagnosis and monitoring of covert hepatic encephalopathy (cHE)in patients with cirrhosis of the liver. The hypothesis is that the CRT method (duration 10-2 minutes) can serve as a tool in the diagnosis and monitoring of cHE and is an alternative to using the Portosystemic Encephalopathy Test (PSE)(duration 20-25 minutes).
Detailed description
Objective: The aim of this project is to investigate whether continuous reaction time measurements (CRT) are suitable as a screening and monitoring tool for covert hepatic encephalopathy (c/mHE).
Method:
Sub-protocol 1: As a part of this PhD protocol 100 healthy individuals and 50 with chronic disease (not liver cirrhosis) will be tested using the CRT and PSE tests. This is to determine the normal range for the PSE test in the Danish population.
Sub-protocol 2: A total of 120 (aprox. 145 to adjust for drop outs) patients with liver cirrhosis from two Danish hospitals will be examined with both CRT and with the test that is the closest we get to a gold standard, namely portosystemic encephalopathy test (PSE). We wish to examine if the CRT test agrees with the PSE test, which may be to time consuming to perform in everyday clinical practice, and with quality of life scores (SF-36 and Sickness Impact Profile). The relationship between the CRT and PSE test and various blood tests and the Charlston co-morbidity score will also be examined.
Sub-protocol 3: Forty-four of the 120 included patients will, regardless of CRT test result, be randomized to treatment with lactulose, rifaximin and branched chain amino acids (BCAA) or placebo lactulose, rifaximin and BCAA. This is to evaluate whether the CRT method is able to detect a response to treatment, and see if changes in psychometric tests (PSE and CRT) are in accordance with quality of life scores and predicts subsequent development of overt hepatic encephalopathy.
Perspective: CRT method should, if it proves good enough, continue to be the Danish test of choice and hopefully be more widely used in our country. The validation of tests for the diagnosis of covert hepatic encephalopathy will give cirrhotic patients with covert hepatic encephalopathy and reduced quality of life the best opportunity to be diagnosed and offered appropriate treatment. If the CRT method is not able to identify a population that benefits from anti-encephalopathy treatment other screening and monitoring tests should be used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti cHE treatment arm | Active comparator | Drug: Lactulose and rifaximin, Dietary Supplement: Branched Chain amino acidsOf 150 included patients aprox. 44 regardless of CRT and PSE test outcome will be offered to enter randomisation and 3 months follow up. Half of 44 patients will receive both lactulose, rifaximin and branched chain aminoacids (Bramino) the other half placebo. |
| Placebo arm | Placebo comparator | Other: PlaceboThe goal of this intervention is to investigate whether the CRT method can detect an expected treatment response after initiation of the 3 named drugs know to ameliorate HE symptoms including psychometric test results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age> 18 years
- Written informed consent
- Speak and understand Danish
- Age > 18 years
- Liver cirrhosis confirmed by biopsy or appropriate clinic and biochemistry, and imaging.
Key exclusion criteria (9 listed)
- Clinical manifest hepatic encephalopathy
- Consumption of psychoactive substances within 6 days of test
- Organic brain disease (i.e. prior stroke, dementia)
- Hypothyroidism
- Renal failure (creatinine> 150 mg / dL)
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 |
|---|---|---|
| Lactulose and rifaximin3 months treatment. lactulose 25 Ml x3 per day. Rifaximin (550 mg) x 2 per day. | Drug | Anti cHE treatment arm |
| Branched Chain amino acids30 grams of branched chain amino acids (Bramino) per day is given to the patients in the antiHE treatment arm along with lactulose and rifaximin. | Dietary supplement | Anti cHE treatment arm |
| PlaceboPatients in the placebo-arm receives both placebo-Bramino, placebo-lactulose and placebo-rifaximin. | Other | Placebo arm |
Primary outcome
Change in Continuous Reaction Time Method versus Portosystemic Encephalopathy Test
Time frame: baseline and 3 months
The investigators are evaluating if the CRT and PSE test are in accordance at inclusion and after 3 months of treatment.
3 secondary outcomes
Change in Continuous Reaction Time Method versus Quality of Life (QoL)
Time frame: baseline and 3 months
Correlation between CRT test and PSE test at inclusion
Time frame: at baseline
Correlation between psychometric test results and quality of life af base line
Time frame: at base line
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 23 Feb 2016.
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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.
Ove Schaffalitzky de Muckadell, Professor study director
Odense University Hospital
Jeppe Gram, PhD, MD study chair
Esbjerg Hospital - University Hospital of Southern Denmark
Hendrik Vilstrup, Professor study chair
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose and rifaximin and Branched Chain amino acids in people with Liver Cirrhosis and Hepatic Encephalopathy, run by Mette Munk Lauridsen at 2 sites 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 9 inclusion and 9 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 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Continuous Reaction Time Method versus Portosystemic Encephalopathy Test (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2016.