Baveno VII - Renewing consensus in portal hypertension.
Roberto de Franchis, Jaime Bosch, Guadalupe Garcia-Tsao...
https://pubmed.ncbi.nlm.nih.gov/35120736/Actively Recruiting
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-05-21
411
Participants Needed
1
Research Sites
13 weeks
Total Duration
Researchers are studying patients with chronic liver disease CLD who have developed acute liver injury. The study aims to use spleen stiffness measurement SSM, a non-invasive tool, to monitor disease progression and establish an early warning model for acute-on-chronic liver failure ACLF. This research also investigates how changes in SSM affect short-term outcomes like 28-day and 90-day illness and death rates in these patients. Participants undergo SSM using the FibroScan Expert 630 device, performed first after admission, repeated around day 5, and again before discharge. This observational study tracks changes in spleen stiffness to assess portal hypertension and its relation to liver failure development. The study does not involve experimental treatments but focuses on monitoring through this device. During the study, patients will be monitored for outcomes including 90-day transplant-free mortality, incidence of acute kidney injury, progression to ACLF, and rates of hospital readmission up to 90 days after discharge. Researchers will collect data from these assessments to understand the prognosis better. Participant involvement includes routine clinical monitoring and repeated SSM assessments over their hospital stay and follow-up period, lasting up to 90 days.
CONDITIONS
SSM Predicts Outcomes of CLD Inpatients With Acute Liver Injury
J
Jinjun Chen, PHD
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Nanfang Hospital, Southern Medical University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From admission to discharge
Participants undergo spleen stiffness measurement (SSM) with the FibroScan® Expert 630 device to monitor portal hypertension and liver disease progression during hospitalization.
3 visits (at admission, day 5±2, and before discharge)
Duration - Up to 90 days after discharge
Participants are observed for outcomes such as transplant-free survival, incidence of acute kidney injury, progression to acute-on-chronic liver failure, and hospital readmission for up to 90 days after discharge.
Follow-up assessments up to Day 90
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Lead Sponsor