Clincosm LogoSign in Get a demo

Stratification of Chronic Alcoholic Liver Diseases (SCALE Study)

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03295812
Collaborator
(none)
3,000
Enrollment
26
Locations
37.5
Anticipated Duration (Months)
115.4
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: standard therapy

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Stratification of Chronic Alcoholic Liver Diseases (SCALE Study) Based on Organs Injury: a Multi-center Prospective Observational Study
Actual Study Start Date :
Nov 16, 2017
Anticipated Primary Completion Date :
Dec 30, 2019
Anticipated Study Completion Date :
Dec 30, 2020

Outcome Measures

Primary Outcome Measures

  1. 4-week mortality [4 weeks]

    mortality rate

  2. 12-week mortality [12 weeks]

    mortality rate

Secondary Outcome Measures

  1. 4-week progression rate [4 weeks]

    The proportion of subjects progressed to acute-on-chronic liver failure within 4 weeks

  2. 24-week mortality [24 weeks]

    mortality rate

  3. 48-week mortality [48 weeks]

    mortality rate

Other Outcome Measures

  1. Risk factors for disease progression within 4 weeks [4 weeks]

    analysis of risk factors for disease progression

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Long-term alcohol consumption (at least one of the followings):

  2. 40g/d for male and >20g/d for female, at least for 5 years;

  3. 50g/d for at least 6 months;

  4. Liver injury (at least one of the followings):

  5. AST>1.0 ULN and AST>ALT;

  6. TBIL>2.0mg/dl;

  7. Ascites;

  8. Hepatic encephalopathy;

  9. Esophageal variceal bleeding;

  10. Hypersplenism

Exclusion Criteria:

  1. Younger than 18 or older than 80;

  2. Other etiologies rather than alcoholic liver disease, including but not limited to the followings:

  3. Acute or chronic virologic hepatitis: Hepatitis A-E, Hepatitis caused by CMV,EBV, etc.

  4. Autoimmune hepatitis, including PSC, PBC, AIH, IgG4 related liver disease

  5. Inherited metabolic liver diseases: Wilson disease;

  6. Others: Schistosomiasis

  7. HIV antibody positive;

  8. Malignancies including but not limited to HCC;

  9. Pregnancy;

  10. Hospital stay less than 24h;

  11. Refuse to sigh the informed consent;

  12. Combined with other improper situations determined by investigators.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanfang Hospital Guangzhou Guangdong China 510515
2 People's hospital of Yangshan Qingyuan Guangdong China
3 Dongguan dalang hospital Dongguan China
4 People's hospital of Foshan Nanhai District Foshan China
5 The First People's Hospital of Foshan Foshan China
6 Guangdong General Hospital Guangzhou China
7 Guangzhou Eighth People's Hospital Guangzhou China
8 The First Affiliated Hospital,Guangzhou University of Chinese Medicine Guangzhou China
9 The First Affiliated Hospital,Jinan University Guangzhou China
10 Huizhou Central Hospital Huizhou China
11 Huizhou Hospital of Traditional Chinese Medicine Huizhou China
12 The First People's Hospital of Huizhou Huizhou China
13 The Sixth People's Hospital of Huizhou Huizhou China
14 The Third People's hospital of Huizhou Huizhou China
15 People's Hospital of Enping Jiangmen China
16 Kaiping Central Hospital Kaiping China
17 The Second People's Hospital of Yuebei Shaoguan China
18 Peking University Shenzhen Hospital Shenzhen China
19 Shenzhen Third People's Hospital Shenzhen China
20 Shunde Hospital of Southern Medical University Shunde China
21 Yangjiang Public Health Hospital Yangjiang China
22 People's Hospital of Yingde City Yingde China
23 Nongken Central Hospital Zhanjiang China
24 The First People's Hospital of Zhaoqing Zhaoqing China
25 Zhaoqing No.2 People's Hospital Zhaoqing China
26 Zhongshan Second People's Hospital Zhongshan China

Sponsors and Collaborators

  • Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Jinjun Chen, Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT03295812
Other Study ID Numbers:
  • 004
First Posted:
Sep 28, 2017
Last Update Posted:
Jan 23, 2018
Last Verified:
Sep 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Diseases
Liver Diseases, Alcoholic

Study Results

No Results Posted as of Jan 23, 2018