Prospective Cohort Study of Complications and Outcomes in Cirrhosis
- Conditions
- Decompensated CirrhosisCMV ReactivationOvert Hepatic Encephalopathy
- Interventions
- Diagnostic Test: Test for CMV reactivation
- Registration Number
- NCT06374511
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 660
- 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)
- Malignancy
- Acquired immune deficiency syndrome
- Received immunosuppressive drugs for non-hepatic reasons
- Received organ transplantations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort Test for CMV reactivation 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.
- Primary Outcome Measures
Name Time Method Incidence of CMV reactivation From enrollment to 90 days 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.
Incidence of hepatic encephalopathy From enrollment to 90 days Patients meet West Haven criteria (Grade 1-4) were diagnosed of hepatic encephalopathy.
- Secondary Outcome Measures
Name Time Method Response to treatment for hepatic encephalopathy (HE) From HE diagnosis to one week and 90 days after treatment 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.
Response to anti-CMV therapy From CMV reactivation to one week and 90 days after treatment 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.
Survival From enrollment to 90 days Transplantation free survival
Trial Locations
- Locations (1)
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China