SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Spleen Stiffness Measurement Predicts Short-term Outcomes of Chronic Liver Disease Inpatients With Acute Liver Injury: a Prospective, Observational and Single-centre Study

Conditions
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Portal Hypertension, End Stage Liver Disease, Jaundice, Liver Dysfunction

Intervention / Treatment
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* Device: FibroScan® Expert 630


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 years and 80 years Chronic liver diseases regardless of etiology Acute liver injury with total bilirubin ≥ 3 mg/dl regardless of inducement Exclusion Criteria: Prior surgery of liver diseases before enrollment such as liver transplantation, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy and partial splenic embolization 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 Receiving Immunosuppressive drugs for reasons rather than chronic liver diseases Diagnosis of hepatocellular carcinoma or other non-liver malignancies during screening period Serious mental illnesses such as anxiety, depressive disorders to obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD) The pregnant Jaundice due to biliary obstruction or cholestasis Unsuitable to participate in this study judging by investigators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FibroScan® 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day mortality | The primary end point was 90-day 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. | Day 90 | 
| 28-day mortality | The primary end point was 28-day mortality, defined as all-cause death within 28 days, including deaths within the initial hospitalization, after discharge, after transfer to other acute care facilities, and requiring readmission. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new onset complications | Development of ascites, bleeding from gastro-oesophageal varices and hepatic encephalopathy. | From admission to Day 90 | 
| Incidence of acute kidney injury (AKI) | 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. | From admission to Day 90 | 
| Rate of progression to acute-on-chronic liver failure (ACLF) | 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). | From admission to Day 90 | 
| Rates for re-admissionin of patients hospitalized with acute liver injury | Re-admission was defined as the first admission for any cause at any ward to any hospital in following discharge from the index admission with acute liver injury. | From discharge to Day 90 | 
| Number of Participants with bacterial infection | All kinds of infection, including pneumonia, SBP, urine tract infection and so on. | From admission to Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End Stage Liver Disease, Chronic Liver Disease, Spleen Stiffness Measurement, Acute-on-Chronic Liver Failure, Portal Hypertension, Jaundice