The Complications and Outcomes of Acutely Decompensated Cirrhosis: a Multi-center Nested Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Incidence of CMV reactivation
研究概览
简要总结
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.
详细描述
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:
- 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;
- The treatment strategy for HE is recorded;
- The HE severity assessments were carried out daily.
CMV reactivation:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Malignancy
- •Acquired immune deficiency syndrome
- •Received immunosuppressive drugs for non-hepatic reasons
- •Received organ transplantations
结局指标
主要结局
Incidence of CMV reactivation
时间窗: 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
时间窗: From enrollment to 90 days
Patients meet West Haven criteria (Grade 1-4) were diagnosed of hepatic encephalopathy.
次要结局
- Response to treatment for hepatic encephalopathy (HE)(From HE diagnosis to one week and 90 days after treatment)
- Response to anti-CMV therapy(From CMV reactivation to one week and 90 days after treatment)
- Survival(From enrollment to 90 days)