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临床试验/NCT05692089
NCT05692089已完成不适用

Incidence of Infective Endocarditis in End Stage Renal Disease Patients on Hemodialysis by Transesophageal Echocardiography in Assuit University Hospital

Assiut University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Incidence of infective endocarditis in end stage renal disease patients on hemodialysis

研究概览

简要总结

  1. To detect in more detail the incidence of infective endocarditis in patients with end stage renal disease (ESRD) on hemodialysis.
  2. To compare the relationship between different forms of haemodialysis access type and the related incidence of infective endocarditis.
  3. To determine individual risk factors, including type of vascular haemodialysis access, previous valve lesion and immunocompromised patients.

详细描述

All patients will undergo TTE and TEE within 36 hours of symptoms. TTE will be performed with a 2.5- or 3.5-MHz phased-array transducer. Patients will fast for more than 4 hours before TEE, which will be performed under local pharyngeal anesthesia; the majority of patients will also receive intravenous midazolam (0.5 to 2.0 mg). A 5-MHz phased-array transducer (either biplane or multiplane) will be used for the transesophageal examination, which consisted principally of two-dimensional imaging and color flow mapping and will be performed without any complications in all patients.

All echocardiograms will be evaluated later during reading sessions by two observers. TTE studies will be defined as technically inadequate if both observers deemed the quality of the images to be insufficient to gain diagnostic information regarding the presence or absence of vegetations or their complications. Findings on TTE and TEE will be separately categorized as indicating high, intermediate, or low probability for endocarditis as follows: high, any definite vegetation and/or abscess or probable vegetation with evidence of otherwise unexplained valvular dysfunction (greater than mild regurgitation or a paravalvular prosthetic leak); intermediate, a probable vegetation without evidence of unexplained valvular dysfunction; and low, no evidence of vegetation or abscess or a possible vegetation without any evidence of regurgitation. 3 sets of blood culture with one hour interval will be withdrawn from the central line from all patients, before stating antibiotics within 24 hours from the onset of symptoms.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Incidence of infective endocarditis in ESRD that on hemodialysis.
  • Must be fit for Transoesophageal ECHO.

排除标准

  • Any patient with sepsis due to causes other than infected vascular access.

结局指标

主要结局

Incidence of infective endocarditis in end stage renal disease patients on hemodialysis

时间窗: Baseline

by transesophageal echocardiography in Assiut university hospital. The endpoint was infective endocarditis diagnosed according to Dukes criteria for diagnosis of infective endocarditis (Roidad et al.,2010) by transthoracic or transesophageal echocardiography and positive repeated blood cultures.

次要结局

  • Infective endocarditis complications(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christin Nashaat Sedeek Aziz

Resident Doctor

Assiut University

研究点 (1)

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