Observing complications and outcomes in patients with decompensated cirrhosis
The Complications and Outcomes of Acutely Decompensated Cirrhosis: a Multi-center Nested Cohort Study
This study looks at the complications and outcomes in people with severe liver disease to see what problems they face and how they can be better managed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 660 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06374511 on ClinicalTrials.gov |
What this trial studies
This multi-center observational study aims to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, focusing on issues like Cytomegalovirus (CMV) reactivation, bacterial infections, hepatic encephalopathy, and Hepatorenal syndrome. Patients diagnosed with this condition will be enrolled, and detailed baseline data along with biological samples will be collected. The study includes rigorous assessments during hospitalization and follow-up interviews at 30 and 90 days post-discharge to monitor complications. Specific protocols will be activated for complications as they arise, ensuring comprehensive data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with a diagnosis of decompensated cirrhosis and associated complications.
Not a fit: Patients with malignancies, AIDS, or those who have received immunosuppressive drugs for non-hepatic reasons will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with decompensated cirrhosis, potentially reducing complications and enhancing patient outcomes.
How similar studies have performed: Other studies have shown success in investigating complications in cirrhosis, but this specific approach focusing on CMV reactivation and detailed follow-up is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Malignancy * Acquired immune deficiency syndrome * Received immunosuppressive drugs for non-hepatic reasons * Received organ transplantations
Where this trial is running
Guangzhou, Guangdong
- Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Jinjun Chen
- Email: chjj@smu.edu.cn
- Phone: 13902246336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.