End Stage Liver Disease, Jaundice, Liver Dysfunction, Portal Hypertension
Conditions
Keywords
End Stage Liver Disease, Chronic Liver Disease, Spleen Stiffness Measurement, Acute-on-Chronic Liver Failure, Portal Hypertension, Jaundice
Brief summary
In this study, a single non-invasive tool, spleen stiffness measurement (SSM), was used to monitor the disease regression of inpatients with chronic liver disease (CLD) and acute liver injury. The present study aimed to establish an early diagnosis warning model for acute-on-chronic liver failure (ACLF) by SSM and investigate the effect of dynamic changes in SSM on the short-term prognosis (28-day, 90-day morbidity and mortality) of inpatients with CLD and acute liver injury.
Detailed description
Portal hypertension is a major complication of cirrhosis and can lead to serious clinical manifestations such as ascites, hepatic encephalopathy, variceal bleeding, etc. Colecchia et al. proposed the use of spleen stiffness measurement (SSM) to dynamically monitor portal pressure and to predict the risk of oesophageal varices. Studies have now demonstrated the utility of SSM in assessing portal hypertension, ruling out high-risk varices, and predicting clinical complications in cirrhotic patients. Furthermore, the Baveno VII consensus of portal hypertension has included SSM in its recommendations for non-invasive screening. Pathogenic triggers, important clinical events (ascites, encephalopathy, etc.), and short-term prognosis in compensated advanced chronic liver disease are associated with portal pressure. Exploring the relationship between portal hypertension and liver failure development would be of great clinical and scientific value. The present study is mainly based on a single non-invasive tool, SSM, to monitor the disease regression of chronic liver disease (CLD) inpatients with acute liver injury, to establish an early warning model for early diagnosis of acute-on-chronic liver failure, and to investigate the effect of dynamic changes in SSM on the short-term prognosis of inpatients with CLD and acute liver injury.
Interventions
DEVICEFibroScan® Expert 630
The SSM by FibroScan 630 was first performed after admission, repeated at the day 5±2 as soon as feasible, and finally evaluated before discharge.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 years and 80 years 2. Chronic liver diseases regardless of etiology 3. Acute liver injury with total bilirubin ≥ 3 mg/dl regardless of inducement
Exclusion criteria
1. Prior surgery of liver diseases before enrollment such as liver transplantation, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy and partial splenic embolization 2. Severe extrahepatic diseases such as chronic obstructive pulmonary disease level IV, chronic kidney disease with end-stage renal failure, myocardial infarction within 3 months before admission 3. Receiving Immunosuppressive drugs for reasons rather than chronic liver diseases 4. Diagnosis of hepatocellular carcinoma or other non-liver malignancies during screening period 5. Serious mental illnesses such as anxiety, depressive disorders to obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD) 6. The pregnant 7. Jaundice due to biliary obstruction or cholestasis 8. Unsuitable to participate in this study judging by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day transplant-free mortality | Day 90 | The primary endpoint was 90-day transplant-free mortality, defined as all-cause death within 90 days, including deaths within the initial hospitalization, after discharge, after transfer to other acute care facilities, and requiring readmission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute kidney injury (AKI) | From admission to Day 90 | AKI is defined as a change in SCr of ≥ 0.3 mg/dl (26.5 μmol/L) in ≤ 48 h, or a 50% increase in SCr from a baseline that is known or presumed to have occurred in the past 7 days. |
| Rate of progression to acute-on-chronic liver failure (ACLF) | From admission to Day 90 | ACLF was defined according to the European Association for the Study of Liver-Chronic Liver Failure (EASL-CLIF) criteria. ACLF grade-1 includes three subgroups: 1) patients with single kidney failure; 2) patients with single failure of the liver, coagulation, circulation or respiration, who had serum creatinine ranging from 1.5 to 1.9 mg/dl and/or mild-to-moderate hepatic encephalopathy; and 3) patients with single cerebral failure who had serum creatinine ranging from 1.5 and 1.9 mg/dl. ACLF grade-2: patients with two organs failure. ACLF grade-3: patients with three organ failures or more. ACLF development: patients with absence of ACLF on admission and progression to ACLF within 28 days. The severity of liver disease was evaluated by the model of end-stage liver disease (MELD) score, Child-Pugh score and CLIF-AD score (in those without ACLF). |
| Rate for readmission of patients hospitalized with acute liver injury | From discharge to Day 90 | The readmission was rehospitalization with liver-related complications (including bacterial infection, variceal bleeding, overt hepatic encephalopathy, or a new onset or worsening of ascites) at any ward to any hospital in the following discharge from the index admission with acute liver injury. |
Countries
China
Contacts
Primary ContactJinjun Chen, PHD
Outcome results
None listed