Our institute, which is a 900-bed tertiary care center, is located in the countryside at Aichi Prefecture in the central area of Japan. For the purpose of estimating how many infective endocarditis (IE) patients in our institute could participate in any randomized clinical trials for the treatment of IE, we reviewed all IE patients who were admitted in our hospital between 2007 and 2019. Patients diagnosed as definite IE according to the modified Duke criteria or by surgical procedure were included in this study. Patients diagnosed as having possible IE according to the modified Duke criteria [8 (link)] were excluded in this study.
The severity of IE was determined by a systemic inflammatory response syndrome (SIRS) score [9 (link)], quick SOFA (qSOFA), and SOFA scores [10 (link)]. The Charlson comorbidity index (CCI) evaluated patents’ comorbidity [11 (link)]. We previously reported that SOFA score was a good predictive marker among IE patients for in-hospital death [7 (link)]. Thus, we evaluated severity of IE by SOFA score.
The patients were divided into two groups: patients who were eligible for clinical trials (RCT appropriate group), and those who were not (RCT inappropriate group). Then, patients’ characteristics (age and sex); pathogens isolated; clinical outcomes such as the treatments and/or results; 30-day or in-hospital mortality; and the reasons of exclusion from the clinical trial were evaluated.
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