RecruitingNCT06173947

SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

411 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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

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.


Locations(1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

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NCT06173947


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