SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNanfang Hospital, Southern Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
FibroScan® Expert 630
DeviceThe SSM by FibroScan 630 was first performed after admission, repeated at the day 5±2 as soon as feasible, and finally evaluated before discharge.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
Day 90Secondary outcomes
1
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.
Time frame
From admission to Day 902
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).
Time frame
From admission to Day 903
Rate for readmission of patients hospitalized with acute liver injury
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.
Time frame
From discharge to Day 90Sponsors and contacts
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Source ClinicalTrials.gov