A Validation Cohort for ACLF Diagnosis and Prognosis

NCT03641872 | Completed

• 1 other identifier: CHINA-ACLF-2
• Study Type: observational
• Target: 1,370
• Locations: 1 country
• Sites: 12

Brief Summary

Acute on chronic liver failure (ACLF) is a distinct entity encompassing the acute deterioration of liver function, culminating in multiple organs failure and high short-term mortality. Definitions and descriptions of ACLF vary between Western and Eastern types, and alcoholism and hepatitis B virus (HBV) are the main etiologies, respectively. To determine whether there are unified diagnostic criteria, severity classification and prognostic model for different etiologies of ACLF. Investigators had launched a multicenter prospective cohort with the same inclusion criteria and disease indicators as those used in the European CANONIC (Chronic liver failure-ACLF in Cirrhosis) study in China，the Ch-CANONIC study(NCT02457637). From Jan 2015 to Dec 2016, 2,600 inpatients with chronic liver disease complicated with ALI and/or AD were recruited. Data were collected during a 28-day hospitalization and continuous follow-ups were performed once a month until 36 months after hospitalization (at least 18 months up to now). Of these patients, 71.5% had HBV-related disease, 1833 had cirrhotic disease, and 767 had non-cirrhotic disease diagnosed by CT scan. Due to the lack of pathological gold standards, the diagnosis of ACLF is based on the clinical assessment of short-term mortality from organ functional parameters. In subsequent statistics and data analysis, investigators focused on (but not limit in) the relationship between short-term mortality and 6 parameters (bilirubin, INR, Creatinine, SpO2/FiO2, mean arterial pressure and West-Haven grade) from CLIF-C OFs (Chronic liver failure-Consortium Organ Failure score). And then a specific mathematical model has been constructed to obtain the available organ failure cutoff values. Subsequently, investigators carried out a diagnostical criteria for ACLF based on the results obtained from the model and get a good internal-validation result through risk ratio. Meanwhile, investigators conducted a precise prediction model for patients' prognosis and achieved a good predictive effect with consistency by AUC internal-validation. In addition, investigators summarized the course and some characteristics of ACLF. Therefore, investigators hope to launch another prospective multi-center cohort study with the same inclusion and exclusion criteria, and continue to recruit 800 to 900 patients (about 30% of the previous cohort) as the external validation cohort for the preliminary results mentioned above.

Conditions

Liver Failure, Acute on Chronic; Liver Dysfunction

Keywords

acute-on-chronic liver disease; acute decompensation; multiple organ failures; acute-on-chronic liver failure

Outcome Measures

Primary Outcomes (2)

• Short-Term Mortality &

  Mortality will be calculated and reported at 28 days,90 days.

  Up to 3 months

• Short-Term Liver Transplantation Rate

  Liver Transplantation Rate will be calculated and reported at 28 days,90 days.Those who undergoing liver transplantation are patients developed life-threatening liver failure. If those patients do not got a chance of transplantation, there would be a high probability that they could die in a very short period of time.So Liver Transplantation Rate is also a Primary Outcome Measure.

  Up to 3 months

Secondary Outcomes (13)

• the Appearance of liver failure

  Up to 28 days

• the Appearance of coagulation failure

  Up to 28 days

• the Appearance of renal failure

  Up to 28 days

• the Appearance of circulative failure

  Up to 28 days

• the Appearance of CNS failure

  Up to 28 days

Study Arms (1)

Acute-on-Chronic Liver Disease

1. chronic liver disease: including chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients, decompensated cirrhosis patients and non-alcoholic fatty liver disease patients. 2. ALI(acute liver injury): including \[ALT \> 3 ULN(upper limited of normal),AST \> 3 ULN or TB \> 2 ULN within 1 week before enrollment\] or AD(acute decompensation) : including \[(having ascites, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding and/or jaundice(TB \> 5 ULN) within 1 month before enrollment)\]. 3. Standary therapy for chronic liver disease with ATI and/or AD

Other: Standary therapy

Interventions

Standary therapy OTHER

Standary therapy for chronic liver disease with ALI and/or AD

Acute-on-Chronic Liver Disease

Eligibility Criteria

• Age: 15 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

chronic liver disease patients（with liver dysfunction more than 6 months） with acute liver injury\[with ALT\>3 ULN),AST\>3NL or TB\>2 ULN within 1 week before enrollment\] or acute decompensation\[having ascites, hepatic encephalopathy, bacterial infection ,gastrointestinal bleeding or jaundice(TB \> 5ULN)within 1 month before enrollment\].

You may qualify if:

• inpatient (hospitalization \>1 days)(including patient in emergency observation wards)chronic liver disease patients including non-alcoholic fatty liver disease patients,chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients and decompensated cirrhosis patients
• having acute liver injury \[ALT(alanine aminotransferase)\>3ULN,AST(aspartate aminotransferase)\>3ULN or TB(total bilirubin)\>2 ULN within 1 week before enrollment\] or acute decompensation\[having ascites, hepatic encephalopathy, bacterial infection ,gastrointestinal bleeding or jaundice(TB\>5NL)within 1 month before enrollment\].

You may not qualify if:

• pregnancy
• hepatocellular carcinoma or other liver malignancies
• malignancy of other organs
• severe chronic extrahepatic disease including chronic obstructive pulmonary disease combined with respiratory failure, coronary heart disease with cardiac function level 3 (NYHA), myocardial infarction in the 3 months before admission, diabetes with severe complications and chronic kidney disease with end-stage renal failure receiving immunosuppressive drugs for reasons other than chronic liver disease

Sponsors & Collaborators

• Hai Li: lead

Study Sites (12)

Ditan Hospital of integrated traditional Chinese and Western Medicine Center

Beijing, Beijing Municipality, 100015, China

Location

Southwest Hospital of Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

Location

Southern hospital infection department

Guangzhou, Guangdong, 510515, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Taihe Hospital

Shiyan, Hubei, 442000, China

Location

Wuhan Union Hospital of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Xiangya hospital of Central South University

Changsha, Hunan, 410008, China

Location

The First Affiliated Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Renji hospital of Shanghai Jiao Tong University School of Medical

Shanghai, Shanghai Municipality, 200001, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200083, China

Location

Infectious Disease Center, The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (21)

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Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Liver Diseases; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Digestive System Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hai Li

  Digestive Department of Renji Hospital,Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Official Title: Professor, Department of Gastroenterology, RenJi Hospital ; Vice Director of the National Digestive Key Laboratory; Youth Commission of Chinese Society of Hepatology.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 22, 2018
• Study Start: September 20, 2018
• Primary Completion: April 21, 2020
• Study Completion: July 31, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

CN (12)