Evaluation of the Usefulness of Echocardiography in Patients With Staphylococcus Aureus Bacteremia at Low Risk of Infective Endocarditis (ET-AUREUS Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 470
- 试验地点
- 2
- 主要终点
- Prevalence of infective endocarditis in low-risk patients according to VIRSTA score
研究概览
简要总结
The goal of this prospective interventionist cohort study is to assess the prevalence of infective endocarditis in patients with Staphylococcus aureus bacteremia at low risk of this complication.
The main questions it aims to answer are:
- Determine whether the risk of infective endocarditis in patients with Staphylococcus aureus bacteriemia identified as low-risk, using the VIRSTA score, is low enough to safely omit transthoracic or transesophageal echocardiography.
- Determine whether the risk of infective endocarditis in patients with Staphylococcus aureus bacteriemia in patients with no identifiable risk factor is low enough to safely omit transthoracic or transesophageal echocardiography.
- Calculate a cost-benefit estimate of omitting echocardiographic testing in patients identified as low-risk by means of the above methods.
Participants will undergo mandatory transthoracic and transesophageal echocardiography during the first 2 weeks from Staphylococcus aureus bacteremia onset.
详细描述
2- Hypothesis: Prospective evaluation of a cohort of patients with OAB, who undergo TEE, TTE, will provide insight into the actual risk of IE in those patients at low risk.
3- Objectives:
- Main objective:
- To estimate the prevalence of IE, defined by the modified Duke criteria, in patients with low risk according to the VIRSTA scale.
- To determine whether the risk of IE in patients with OAB identified as low risk using the VIRSTA scale is low enough to safely omit transthoracic or transesophageal echocardiography using this scale.
- Secondary objectives
- To determine whether the risk of IE in patients with SAAB identified as low risk using the PREDICT or POSITIVE scales is low enough to safely omit transthoracic or transesophageal echocardiography.
- To identify risk factors for IE in patients with SAAB.
- Determine whether the risk of IE in patients with no risk factors is low enough to safely omit transthoracic or transesophageal echocardiography.
- Estimate the number of echocardiographies that could be avoided by these approaches.
- Estimate the cost-benefit of omitting echocardiographic testing in patients identified as low risk by the above methods.
3- Material and methods:
*Design: Multicenter prospective cohort study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Single arm study, no masking needed
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 Staphylococcus aureus bacteremia
排除标准
- •Previous episode of Staphylococcus aureus bacteremia.
- •Pregnant women
- •Patients younger than 18 years old.
- •High estimated probability of death during 72 hours of study inclusion.
- •Patients with contraindication of transesophageal echocardiography, including: esophageal varices, other serious esophageal diseases (including tumors, perforation, diverticulum and previous esophageal surgery), severe coagulopathy (platelets count lower than 50.000 cel/mL or I.N.R above 4), low consciousness, recent upper gastroesophageal bleeding, serious espinal vertebrae pathology (previous radiotherapy, active spondylodiscitis, severe spondylarthrosis)
- •Abscense of written informed consent or patient's negative to undergo echocardiography evaluation.
结局指标
主要结局
Prevalence of infective endocarditis in low-risk patients according to VIRSTA score
时间窗: 3 years
If the prevalence of infective endocarditis is lower than 0.5% it would be considered that no echocardiography is needed to exclude infective endocarditis. If the prevalence is greater than 5%, a transesophageal echocardiography will be considered needed. If the prevalence is between 0.5-5%, transesophageal echocardiography will be consireded needed unless the prevalence of those patients with negative transthoracic echocardiography is below 1%.
次要结局
- Prevalence of infective endocarditis in low-risk patients according to PREDICT score(3 years)
- Prevalence of infective endocarditis in low-risk patients according to POSITIVE score(3 years)
- Prevalence of infective endocarditis in patients with no identifiable risk factor(3 years)
研究者
Antonio Ramos Martinez
Dr.
Puerta de Hierro University Hospital