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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06173947
Other study ID # NFEC-2023-495
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date September 30, 2025

Study information

Verified date March 2024
Source Nanfang Hospital, Southern Medical University
Contact Jinjun Chen, PHD
Phone 86-18588531001
Email chjj@smu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


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Study Design


Intervention

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.

Locations

Country Name City State
China Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (19)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Incidence of new onset complications Development of ascites, bleeding from gastro-oesophageal varices and hepatic encephalopathy. From admission to Day 90
Secondary 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
Secondary 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
Secondary 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
Secondary Number of Participants with bacterial infection All kinds of infection, including pneumonia, SBP, urine tract infection and so on. From admission to Day 90
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