An observational study in Decompensated Cirrhosis, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Observational
Study Goal The goal of this multicenter, prospective observational cohort study is to develop and validate a multimodal predictive model that integrates portal hypertension, inflammation, and liver function indicators to predict the risk of adverse clinical outcomes (e.g., further decompensation, mortality, recompensation, and liver failure) in patients with decompensated cirrhosis.
Target Population The study will enroll adults aged 18-80 years with chronic liver disease of any etiology who have experienced at least one decompensating event (e.g., ascites, variceal bleeding, overt hepatic encephalopathy, jaundice, or infection requiring treatment) at or prior to enrollment.
Main Questions It Aims to Answer
Comparison Group Researchers will compare the performance of the newly developed multimodal model against established traditional prognostic tools, including the MELD, MELD-Na, and Child-Pugh scores, to assess whether the new model provides superior predictive accuracy, better risk reclassification, and greater clinical net benefit.
Participants Will
345 studies on the registry are indexed under Hypertension, Portal; 110 are open to participants now.
This study's planned enrollment of 2,235 is above the median of 151 across 128 observational studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 99 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults (18-80 years) with decompensated cirrhosis of any etiology, having at least one prior decompensation event (ascites, variceal bleeding, encephalopathy, jaundice >3 mg/dL, or infection). Excludes active malignancy (except curable skin/thyroid), prior transplant, critical illness (survival \<72h), and pregnancy.
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Have experienced at least one decompensating event prior to or at enrollment, defined as any of the following:
① Gastroesophageal variceal bleeding confirmed by endoscopy;
② Overt hepatic encephalopathy;
③ Moderate to large ascites confirmed by imaging, or requiring paracentesis for therapeutic drainage;
④ Jaundice (serum total bilirubin >3 mg/dL);
⑤ Infection requiring treatment.
Exclusion Criteria:
Participants receive standard-of-care medical management for decompensated cirrhosis, including regular 3-month follow-up visits, laboratory tests, and imaging examinations, as determined by their treating physicians per clinical practice guidelines. No study-specific therapeutic interventions, randomization, or treatment allocation are applied. In addition, participants who provide voluntary informed consent will undergo the following study-related procedures: Free magnetic resonance elastography (MRE) examination, offered to participants who are clinically scheduled for a routine abdominal MRI, to assess liver stiffness and fibrosis non-invasively at no cost. All data collected (demographics, clinical history, laboratory results, imaging findings, and patient-reported outcome scales) are derived from routine clinical care and are used solely for prognostic model development and validation.
Incidence of Further Decompensation at 1 Year
Further decompensation is defined per Baveno VII criteria as any of the following: (1) occurrence of a second portal hypertension-related decompensating event (ascites, variceal bleeding, or hepatic encephalopathy); (2) recurrent variceal bleeding, recurrent ascites requiring ≥3 large-volume paracenteses within 1 year, recurrent hepatic encephalopathy, spontaneous bacterial peritonitis, and/or hepatorenal syndrome-acute kidney injury; or (3) development of ascites or hepatic encephalopathy after surgery in patients with variceal bleeding as the sole prior event.
Time frame: Within 12 months after enrollment
6-Week Liver-Related Mortality Rate
Death directly attributed to liver disease or its immediate complications (e.g., liver failure, variceal rebleeding, infections).
Time frame: Within 6 weeks after enrollment
1-Year Liver-Related Mortality Rate
Death directly attributed to liver disease or its immediate complications (e.g., liver failure, variceal rebleeding, infections).
Time frame: Within 12 months after enrollment
Incidence of Liver Failure at 1 Year
Defined per 2023 EASL ACLF criteria: total bilirubin ≥12 mg/dL plus any of: (1) INR ≥2.5; (2) serum creatinine ≥2.0 mg/dL or need for RRT; (3) hepatic encephalopathy ≥ grade 3 (West Haven); (4) need for vasopressors; or (5) PaO₂/FiO₂ ≤200 or SpO₂/FiO₂ ≤214.
Time frame: Within 12 months after enrollment
Recompensation Rate at 2 Years
Per Baveno VII consensus: sustained resolution of ascites, hepatic encephalopathy, and variceal bleeding with stable improvement in liver function for ≥12 months after etiological treatment.
Time frame: Within 24 months after enrollment
Recompensation Rate at 3 Years
Per Baveno VII consensus: sustained resolution of ascites, hepatic encephalopathy, and variceal bleeding with stable improvement in liver function for ≥12 months after etiological treatment.
Time frame: Within 36 months after enrollment
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Sep 2029, 35 months later.
Of 61 non-industry observational studies under Hypertension, Portal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 256. This study's planned 35 months is below that.
Counting every sponsor, half of 64 studies reached it within 43 months; a quarter within 30 and three quarters within 256.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The Second Affiliated Hospital of Chongqing Medical University