Prospective Cohort Study of Complications and Outcomes in Cirrhosis

Decompensated Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374511
• Other study ID #: NFEC-2023-546
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: Jinjun Chen
• Phone: 13902246336
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: December 31, 2025
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• CMV Reactivation
• Decompensated Cirrhosis
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis
• Overt Hepatic Encephalopathy

Intervention

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

Locations

Country	Name	City	State
China	Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CMV reactivation	Cytomegalovirus DNA was quantified in stored plasma samples using real-time PCR (polymerase chain reaction) assay. DNA extraction was performed on 200 µL of plasma using a QIAamp DNA blood kit (Qiagen, German). Then, 25 µL of Tris (10 mM, pH 8.0) was used to elute the DNA, and 10 µL of the DNA was used for each PCR reaction. The minimum detection level was 102 copies/ml of plasma and values over this lower detection limit were considered to be CMV reactivation positive.	From enrollment to 90 days
Primary	Incidence of hepatic encephalopathy	Patients meet West Haven criteria (Grade 1-4) were diagnosed of hepatic encephalopathy.	From enrollment to 90 days
Secondary	Response to anti-CMV therapy	Patients with CMV reactivation may receive anti-CMV therapy; response to anti-CMV therapy was defined as patients' CMV-DNA test negative at more than 2 times.	From CMV reactivation to one week and 90 days after treatment
Secondary	Response to treatment for hepatic encephalopathy (HE)	Patients with hepatic encephalopathy may receive lactulose and (or) rifaximin; Patients' extent of HE change to Grade 0 (West Haven criteria) or decreased 2 grade from the baseline were be defined to response to the HE treatment.	From HE diagnosis to one week and 90 days after treatment
Secondary	Survival	Transplantation free survival	From enrollment to 90 days