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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.
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:
CMV reactivation:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test for CMV reactivation | Diagnostic Test | All enrolled patients are monitored for CMV reactivation and hepatic encephalopathy using regular clinical tests or library test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Response to treatment for hepatic encephalopathy (HE) |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with liver cirrhosis, irrespective of time and circumstances of diagnosis, comorbidities and severity of disease will be offered inclusion in the cohort.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinjun Chen | Contact | 13902246336 | chjj@smu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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Plasma and buffy coat from whole blood, urine samples, stool samples and peripheral blood mononuclear cell
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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 |
| Survival | Transplantation free survival | From enrollment to 90 days |