CirrhosisNCT01846819
Factors Associated With End Stage Liver Disease
An observational study of Cirrhosis and Hepatic Encephalopathy, run by NYU Langone Health at 1 site in United States.
Trial summary
100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a comprehensive clinical evaluation for severity of liver disease, anemia, depression, and fatigue. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Hepatic Encephalopathy, Fatigue
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2014
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients experiencing cirrhosis of the liver
Who may be able to join
- male or female, age b/w 18-70 years, inclusive
- willingly and able to provide written consent
- Diagnosed with Cirrhosis
- Able to read and write in English
Who cannot join
- Inability to provide consent
- Not within age range of 18-70 years, inclusive
- Not diagnosed with Cirrhosis
- Unable to read or write in English
- Unable to walk
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU School of Medicine, Schwartz Health Care Center Suite 4C
New York, New York, 10016
About this study
100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a comprehensive clinical evaluation for severity of liver disease, anemia, depression, and fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the 6-minute walk test (6MWT), a standardized exercise test that measures the distance that a patient is capable of walking in 6 minutes (6MWD). Depression will be assessed by using three well-known questionnaires. The SF-36, Beck's Depression Inventory (BDI-II), EQ-5D, and the Psychological General Well-Being Index (PGWBI). Univariate analysis will be performed to select the factors that potentially are associated with the scores as indicated by a P value <.20; the selected factors will then be entered in a stepwise regression to create a multivariate model giving the combination of factors that are significantly associated with the measure of fatigue and depression. Hemoglobin (Hb) levels will then be added to the model in order to test its significance while controlling for the other factors.
Read the detailed description
100 ambulatory patients with cirrhosis will be prospectively evaluated for severity of liver disease, anemia, and fatigue; exclusion criteria includes chronic renal insufficiency and recent alcohol use, gastrointestinal bleeding, and infection.
Patients will first be identified and be asked to partake in the study. They will be asked to read over an informed consent form. Subsequently, they will be asked to fill out a depression questionnaire before performing the 6MWT. During the 6MWT the patient will be walking up and down two designated points 100 feet apart. They will be asked to walk for 6 minutes using any walking aids and resting as needed. Their final distance will be recorded. They will then be asked to fill out the FIS fatigue questionnaire.
Severity of liver disease will be assessed through a detailed clinical examination of ascites grade, hepatic encephalopathy, history of complications from cirrhosis (hepatic coma, spontaneous bacterial peritonitis, gastrointestinal bleeding), standard liver tests (TBili, Albumin, INA), platelet count as a parameter of splenic sequestration and portal hypertension, Child-Pugh score, MELD (Model of End-stage Liver Disease) score. Anemia will be assessed with hemoglobin levels. Depression will be assessed with the following questionnaires: Beck Depression Inventory (BDI), EQ-5D, Psychological General Well-Being Index (PGWBI), LDQOL. Fatigue will be assessed with the FIS and 6 Minute Walk Test. Hepatic Encephalopathy will be assessed with the number connection, digit-symbol coding and inhibitory control test. Sexual function will be assessed by the Sexual Problems and Sexual Function scales of the LDQOL. The results will be scored and compared to depression quality of life, and end-stage liver disease factors.
- Conditions
- Cirrhosis, Hepatic Encephalopathy, Fatigue, Depression
- Medical subject headings
- Fibrosis, Hepatic Encephalopathy, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory cirrhotic patients | Severity of liver disease will be assessed through a detailed clinical examination of ascites grade, history of complications from cirrhosis (hepatic coma, spontaneous bacterial peritonitis, gastrointestinal bleeding), laboratory tests (TBili, Albumin, INR, hemoglobin). Depression will be assessed with the following questionnaires: Beck Depression Inventory (BDI), EQ-5D, Psychological General Well-Being Index (PGWBI), LDQOL. Fatigue will be assessed with the FIS and 6 Minute Walk Test. Hepatic Encephalopathy will be assessed with the number connection, digit-symbol coding and inhibitory control test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Patients undergo 6 minute walk test and complete Fisk Impact Scale (Fatigue Questionaire)
Measured: 20 minutes
Secondary outcomes (3)
Hepatic Encephalopathy
Patients do psychometric tests (Number Connection Test, Symbol Digit Coding Test, and Inhibitory Control Test)
Measured: 20 minutes
Depression
Patients complete Beck Depression Inventory Questionnaire
Measured: 5 min
Quality of Life
Patients complete several questionaires (Liver disease quality of Life, EQ-5D, Psychological Well-Being index)
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Sigal, M.D., Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846819
- Sponsor's protocol ID
- 11-00843
- Status last verified
- Jan 2017
- First submitted
- 1 May 2013
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With End Stage Liver Disease
- ClinicalTrials.gov ID
- NCT01846819
- Acronym / sponsor ID
- 11-00843
- Conditions
- Cirrhosis, Hepatic Encephalopathy, Fatigue, Depression
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 May 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.
100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a comprehensive clinical evaluation for severity of liver disease, anemia, depression, and fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the 6-minute walk test (6MWT), a standardized exercise test that measures the distance that a patient is capable of walking in 6 minutes (6MWD). Depression will be assessed by using three well-known questionnaires. The SF-36, Beck's Depression Inventory (BDI-II), EQ-5D, and the Psychological General Well-Being Index (PGWBI). Univariate analysis will be performed to select the factors that potentially are associated with the scores as indicated by a P value <.20; the selected factors will then be entered in a stepwise regression to create a multivariate model giving the combination of factors that are significantly associated with the measure of fatigue and depression. Hemoglobin (Hb) levels will then be added to the model in order to test its significance while controlling for the other factors.
Detailed description
100 ambulatory patients with cirrhosis will be prospectively evaluated for severity of liver disease, anemia, and fatigue; exclusion criteria includes chronic renal insufficiency and recent alcohol use, gastrointestinal bleeding, and infection.
Patients will first be identified and be asked to partake in the study. They will be asked to read over an informed consent form. Subsequently, they will be asked to fill out a depression questionnaire before performing the 6MWT. During the 6MWT the patient will be walking up and down two designated points 100 feet apart. They will be asked to walk for 6 minutes using any walking aids and resting as needed. Their final distance will be recorded. They will then be asked to fill out the FIS fatigue questionnaire.
Severity of liver disease will be assessed through a detailed clinical examination of ascites grade, hepatic encephalopathy, history of complications from cirrhosis (hepatic coma, spontaneous bacterial peritonitis, gastrointestinal bleeding), standard liver tests (TBili, Albumin, INA), platelet count as a parameter of splenic sequestration and portal hypertension, Child-Pugh score, MELD (Model of End-stage Liver Disease) score. Anemia will be assessed with hemoglobin levels. Depression will be assessed with the following questionnaires: Beck Depression Inventory (BDI), EQ-5D, Psychological General Well-Being Index (PGWBI), LDQOL. Fatigue will be assessed with the FIS and 6 Minute Walk Test. Hepatic Encephalopathy will be assessed with the number connection, digit-symbol coding and inhibitory control test. Sexual function will be assessed by the Sexual Problems and Sexual Function scales of the LDQOL. The results will be scored and compared to depression quality of life, and end-stage liver disease factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory cirrhotic patients | – | –Severity of liver disease will be assessed through a detailed clinical examination of ascites grade, history of complications from cirrhosis (hepatic coma, spontaneous bacterial peritonitis, gastrointestinal bleeding), laboratory tests (TBili, Albumin, INR, hemoglobin). Depression will be assessed with the following questionnaires: Beck Depression Inventory (BDI), EQ-5D, Psychological General Well-Being Index (PGWBI), LDQOL. Fatigue will be assessed with the FIS and 6 Minute Walk Test. Hepatic Encephalopathy will be assessed with the number connection, digit-symbol coding and inhibitory control test. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients experiencing cirrhosis of the liver
Key inclusion criteria (4 listed)
- male or female, age b/w 18-70 years, inclusive
- willingly and able to provide written consent
- Diagnosed with Cirrhosis
- Able to read and write in English
Key exclusion criteria (5 listed)
- Inability to provide consent
- Not within age range of 18-70 years, inclusive
- Not diagnosed with Cirrhosis
- Unable to read or write in English
- Unable to walk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue
Time frame: 20 minutes
Patients undergo 6 minute walk test and complete Fisk Impact Scale (Fatigue Questionaire)
3 secondary outcomes
Hepatic Encephalopathy
Time frame: 20 minutes
Depression
Time frame: 5 min
Quality of Life
Time frame: 10 min
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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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.
Samuel Sigal, M.D. principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Hepatic Encephalopathy, run by NYU Langone Health at 1 site in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 25 Jan 2017. 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 United States. 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. 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 was stopped early. Results are not available in the source record.
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?
Fatigue (time frame: 20 minutes). 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 25 Jan 2017.