Clinical trial NCT06173947: SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury
Official title: Spleen Stiffness Measurement Predicts Short-term Outcomes of Chronic Liver Disease Inpatients With Acute Liver Injury: a Prospective, Observational and Multicentre Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End Stage Liver Disease
Jaundice
Liver Dysfunction
Portal Hypertension
Keywords: End Stage Liver Disease
Chronic Liver Disease
Spleen Stiffness Measurement
Acute-on-Chronic Liver Failure
Portal Hypertension
Jaundice
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with cirrhosis or other chronic liver diseases and hospitalized for acute liver injury with total bilirubin \[TB\] ≥3 mg/dl were admitted.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 90-day transplant-free mortality
timeFrame: Day 90
Secondary outcomes:
measure: Incidence of acute kidney injury (AKI)
timeFrame: From admission to Day 90
measure: Rate of progression to acute-on-chronic liver failure (ACLF)
timeFrame: From admission to Day 90
measure: Rate for readmission of patients hospitalized with acute liver injury
timeFrame: From discharge to Day 90
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jinjun Chen, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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