Prediction of Multidrug-resistant Bacterial Infection in Patients with Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,774
- 试验地点
- 1
- 主要终点
- Infection caused by multidrug-resistan organism
研究概览
简要总结
The aim of this study is to identify predictive factors of infections caused by multidrug-resistant organisms in patients with cirrhosis and to develop and validate (internally and externally) a predictive model that might be useful to use in clinical settings to stratify the risk and lead clinical decision-making strategies.
详细描述
Background Bacterial infections are currently recognized as a surrogate for the final stage of chronic liver disease. The relevance of bacterial infections as a prognostic factor has been clearly stated in a meta-analysis that found that bacterial infections increase mortality four-fold in this population, considering 30% of patients die within one month, and another 30% die one year after these infections are diagnosed.
Patients with cirrhosis are particularly prone to be colonized or infected by multidrug-resistant organisms because they are frequently admitted to hospitals, they require admissions to critical care units and receive organ support, they are exposed to invasive procedures and they frequently receive therapeutic and prophylactic antibiotics.
Prior studies in patients with cirrhosis mainly described risk factors of infections by multidrug-resistant organisms infections, without providing a risk assessment. Therefore, it would be desirable to count on tools to identify which patients are at higher risk than others of presenting a multidrug-resistant organism infection, such as a predictive model that might help practitioners to select the empirical antibiotic treatment.
Objectives To identify easily accessible predictors of multidrug resistance in adult patients with cirrhosis at the time of bacterial infection diagnosis or suspicion.
To develop and validate (goodness of fit, discrimination, calibration, and diagnostic performance) predictive models of multidrug resistance in adult patients with cirrhosis at the time of bacterial infection
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •age ≥ 18 years
- •with cirrhosis
- •who presented their first confirmed diagnosis of bacterial infection during the study period, either at admission or during hospitalization
排除标准
- •hepatocellular carcinoma beyond the Milan criteria;
- •extrahepatic malignancy;
- •severe extrahepatic disease (congestive heart failure [New York Heart Association stage3], chronic obstructive pulmonary disease [Global Initiative for Chronic Obstructive Lung Disease stage 3]; chronic kidney disease requiring renal replacement therapy [RRT]);
- •previous solid organ transplantation;
- •human immunodeficiency viral infection;
- •use of immunosuppressive drugs other than corticosteroids for the treatment of severe acute alcoholic hepatitis; and
- •inability to provide written informed consent.
结局指标
主要结局
Infection caused by multidrug-resistan organism
时间窗: 24-48 hours (it is a cross sectional study)
Aqcuired resitance to at least one antibiotic of three different antibiotic families
次要结局
未报告次要终点
研究者
SEBASTIAN MARCIANO
Director, Head of Hepatology, Principal Investigator, Clinical Professor
Hospital Italiano de Buenos Aires