Clinical trial NCT06374511: Prospective Cohort Study of Complications and Outcomes in Cirrhosis
Official title: The Complications and Outcomes of Acutely Decompensated Cirrhosis: a Multi-center Nested Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Decompensated Cirrhosis
CMV Reactivation
Overt Hepatic Encephalopathy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Incidence of CMV reactivation
timeFrame: From enrollment to 90 days
measure: Incidence of hepatic encephalopathy
timeFrame: From enrollment to 90 days
Secondary outcomes:
measure: Response to anti-CMV therapy
timeFrame: From CMV reactivation to one week and 90 days after treatment
measure: Response to treatment for hepatic encephalopathy (HE)
timeFrame: From HE diagnosis to one week and 90 days after treatment
measure: Survival
timeFrame: From enrollment to 90 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References: