A Single-center, Open Study to Investigate Cytokine Levels in Patients With Hepatic Cirrhosis Before the Development of Significant Infection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation.
研究概览
简要总结
The aim of this study is to test whether the oscillation of cytokine concentrations in serum is able to predict the development of infection in patients with liver cirrhosis.
详细描述
Patients with liver cirrhosis frequently develop bacterial, viral or fungal infections which are the main trigger for decompensation of cirrhosis and development of complications and thereby infection hugely impacts morbidity and mortality in these patients. However, there is no clinical test available that allows rapid, on-site decision making if a patient is likely to develop an infection. The purpose of this study is to measure cytokines interleukin (IL) 6, IL8, IL10 and TNFalpha in patients with liver cirrhosis over a long follow-up period and test whether these inflammatory markers are able to predict the occurrence of infection before it becomes clinically significant. For this purpose, one hundred fifty consecutive patients with diagnosis of liver cirrhosis will be followed bi-monthly for 18 months. Blood samples will be collected for the cytokine measurements and infection cases will be reported at each study visit.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical, radiological and/or histological evidence of liver cirrhosis
- •Age above 18 (inclusive) at the time of screening
- •Able and willing to give written informed consent and to comply with the requirements of the study
排除标准
- •Infection during the last 14 days before screening
- •Gastrointestinal bleeding within the last 14 days before screening
- •Antibiotic therapy at the time of screening (except prophylaxis of spontaneous bacterial peritonitis)
- •Shock or cardiac failure requiring inotrope treatment at the time of screening
- •Hepatic encephalopathy grade >2
- •Findings suggestive of organic nephropathy or a serum creatinine level of more than 2 mg/dl
- •Human immunodeficiency virus infection at time of inclusion
- •Use of immunomodulating agents within one month prior to screening (e.g. steroids)
- •Any disease (e.g., advanced neoplasia) that could affect the short-term prognosis
- •Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
结局指标
主要结局
Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation.
时间窗: 18 months
次要结局
- Mortality(18 months)
- Hospitalisation for reasons other than infection(18 months)
- All infections(18 months)
- Duration of hospitalisation(18 months)
研究者
Vanessa Stadlbauer-Koellner, MD
MD
Medical University of Graz