Prospective Cohort Study of Complications and Outcomes in Cirrhosis

NCT06374511 | Recruiting DMC

• 1 other identifier: NFEC-2023-546
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 1

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.

Conditions

Decompensated Cirrhosis; CMV Reactivation; Overt Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (2)

• 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

• Incidence of hepatic encephalopathy

  Patients meet West Haven criteria (Grade 1-4) were diagnosed of hepatic encephalopathy.

  From enrollment to 90 days

Secondary Outcomes (3)

• Response to anti-CMV therapy

  From CMV reactivation to one week and 90 days after treatment

• Response to treatment for hepatic encephalopathy (HE)

  From HE diagnosis to one week and 90 days after treatment

• Survival

  From enrollment to 90 days

Study Arms (1)

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.

Diagnostic Test: Test for CMV reactivation

Interventions

Test for CMV reactivation DIAGNOSTIC_TEST

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

Also known as: Test and examine the severity of hepatic encephalopathy

Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with liver cirrhosis, irrespective of time and circumstances of diagnosis, comorbidities and severity of disease will be offered inclusion in the cohort.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and buffy coat from whole blood, urine samples, stool samples and peripheral blood mononuclear cell

Central Study Contacts

Jinjun Chen

CONTACT

13902246336; chjj@smu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 18, 2024
• Study Start: January 1, 2024
• Primary Completion: April 4, 2024
• Study Completion: December 31, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

CN (1)