Prospective Cohort Study of Complications and Outcomes in Cirrhosis

NCT ID: NCT06374511

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 660 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

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 CMV reactivation, bacterial infections, hepatic encephalopathy, and Hepatorenal syndrome. Patients diagnosed with acute decompensated cirrhosis were enrolled. Upon enrollment, detailed baseline data were collected and samples including ascites, feces, plasma, urine and PBMC were harvested. Following enrollment, patients were subjected to a rigorous follow-up regimen extending over a period of 90 days. Complications were assessed every 3-4 days during hospitalization through a combination of laboratory and clinical evaluations. Post-discharge follow-up was conducted through telephonic interviews at Day 30 and Day 90. Upon the emergence of new complications, such as infections (viral, bacterial or fungal) or hepatic encephalopathy, a detailed, complication-specific protocol was activated (Per complications protocols as follows).

Special complications protocols:

Hepatic encephalopathy:

1. The feces, plasma, and urine were collected at hepatic encephalopathy diagnosis before treatment and at Day 4, 7, 14 since hepatic encephalopathy treatment. If patients were discharged before14 days post-hepatic encephalopathy, the sample at discharge were collocated;

2. The treatment strategy for HE is recorded;

3. The HE severity assessments were carried out daily.

CMV reactivation:

1. The patients' plasma were collected twice a week for the assessment of CMV reactivation; The patients' peripheral blood mononuclear cells (PBMC) samples were collected at baseline and at the time of diagnosis of CMV reactivation;

2. The treatment strategy for CMV is recorded.

Conditions

Decompensated Cirrhosis; CMV Reactivation; Overt Hepatic Encephalopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort

Inpatients diagnosed with decompensated cirrhosis form the Hepatology Unit, Nanfang Hospital, China. All patients with clinically verified diagnosis, irrespective of disease stage and etiology is included.

Test for CMV reactivation

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Test for CMV reactivation

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Test and examine the severity of hepatic encephalopathy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinjun Chen

Role: CONTACT

chjj@smu.edu.cn

13902246336

Facility Contacts

Jinjun Chen, PHD

Role: primary

chjj@smu.edu.cn

86-18588531001

Other Identifiers

NFEC-2023-546

Identifier Type: -

Identifier Source: org_study_id