RecruitingNCT06374511

Prospective Cohort Study of Complications and Outcomes in Cirrhosis

The Complications and Outcomes of Acutely Decompensated Cirrhosis: a Multi-center Nested Cohort Study


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

660 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This is a multi-center, nested cohort study intended to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, especially focused on Cytomegalovirus (CMV) reactivation, bacterial infections, hepatic encephalopathy, and Hepatorenal syndrome. Patients diagnosed with acutely decompensated cirrhosis were enrolled. Upon enrollment, detailed baseline data were collected and samples were harvested. Complications were assessed during hospitalization. Post-discharge follow-up was conducted through telephonic interviews at Day 30 and Day 90.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • Informed written consent
  • Age between 18 years and 80 years
  • Cirrhosis based on liver histology or a combination of characteristic clinical, biochemical, and imaging features
  • Complications of decompensated cirrhosis (ascites, gastrointestinal bleeding and hepatic encephalopathy)

Exclusion Criteria4

  • Malignancy
  • Acquired immune deficiency syndrome
  • Received immunosuppressive drugs for non-hepatic reasons
  • Received organ transplantations

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Interventions

DIAGNOSTIC_TESTTest for CMV reactivation

All enrolled patients are monitored for CMV reactivation and hepatic encephalopathy using regular clinical tests or library test


Locations(1)

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

Guangzhou, Guangdong, China

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NCT06374511


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