SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury

Recruiting

• Conditions: Jaundice; End Stage Liver Disease; Portal Hypertension; Liver Dysfunction

• Registration Number: NCT06173947
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study First Submitted: 2023-11-24
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-18
• Study Start: 2024-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 411

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China