SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury

NCT06173947 | Recruiting

• 1 other identifier: NFEC-2023-495
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 90-day transplant-free mortality

  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.

  Day 90

Secondary Outcomes (3)

• Incidence of acute kidney injury (AKI)

  From admission to Day 90

• Rate of progression to acute-on-chronic liver failure (ACLF)

  From admission to Day 90

• Rate for readmission of patients hospitalized with acute liver injury

  From discharge to Day 90

Interventions

FibroScan® Expert 630 DEVICE

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.

Also known as: FibroScan® (FibroScan® expert 630 machine; Echosens, Paris, France), Spleen mode (SSM@100 Hz), Spleen vibration-controlled transient elastography (VCTE) settings (SSM@100 Hz), Spleen-dedicated examination based on VCTE (SSM@100 Hz)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (19)

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Biospecimen

Retention: SAMPLES WITH DNA

The study will collect biospecimens, including whole blood.

MeSH Terms

Conditions

End Stage Liver Disease; Jaundice; Liver Diseases; Hypertension, Portal; Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Digestive System Diseases; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Liver Failure, Acute

Study Officials

• Jinjun Chen, PHD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinjun Chen, PHD

CONTACT

86-18588531001; chjj@smu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 18, 2023
• Study Start: January 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The deidentified individual patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than six months after publication.
• Access Criteria: Data will be made available on request from the corresponding author.

Locations

CN (1)