An observational study in Alcoholic Liver Disease, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 26 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Nanfang Hospital, Southern Medical University · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Recent years, the European Association for the Study of the Liver-chronic liver failure (EASL-CLIF) has defined and graded acute-on-chronic liver failure (ACLF) based on CANONIC study which enrolled cirrhotic patients with acute decompensation. However, the characteristics and definitions of ACLF in non-cirrhotic patients with acute deterioration of liver function and organs injury or failure remain to be clear. As for patients who don't fulfil ACLF criteria, there might be a subgroup with high risk of progression (>25%) and a moderate 4-week mortality rate (>7%), which can be defined as "pre-ACLF", while the others are just chronic liver disease with "mere" liver injury or decompensation. This stratification system was primarily verified in a previous retrospective cohort which enrolled Hepatitis B patients only. The stratification criteria for chronic alcoholic liver disease needs to be further defined in detail. Therefore, investigators plan to prospectively recruit 3000 chronic alcoholic hospitalized patients with liver dysfunction from 24 hepatology departments in China, aiming to propose a stratified diagnostic system for chronic alcoholic patients based on organs injury. Meanwhile, risk factors of disease progression and short-term mortality will be analyzed, while characteristics and prognosis will be compared between patients with and without cirrhosis.
74 studies on the registry are indexed under Liver Diseases, Alcoholic; 25 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 439 across 28 observational studies indexed under Liver Diseases, Alcoholic.
Browse Liver Diseases, Alcoholic studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be selected from all in-patients in 24 hepatology departments
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Long-term alcohol consumption (at least one of the followings):
Liver injury (at least one of the followings):
Exclusion Criteria:
Other etiologies rather than alcoholic liver disease, including but not limited to the followings:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard therapy,non-interventional study
4-week mortality
mortality rate
Time frame: 4 weeks
12-week mortality
mortality rate
Time frame: 12 weeks
4-week progression rate
The proportion of subjects progressed to acute-on-chronic liver failure within 4 weeks
Time frame: 4 weeks
24-week mortality
mortality rate
Time frame: 24 weeks
48-week mortality
mortality rate
Time frame: 48 weeks
Risk factors for disease progression within 4 weeks
analysis of risk factors for disease progression
Time frame: 4 weeks
Started Nov 2017 (actual). Primary completion is estimated for Dec 2019, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nanfang Hospital, Southern Medical University →