An observational study in Infective Endocarditis and End Stage Renal Disease, sponsored by Assiut University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Assiut University · Observational
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or a possible vegetation without any evidence of regurgitation. 3 sets of blood culture with one hour interval will be withdrawn from the central line from all patients, before stating antibiotics within 24 hours from the onset of symptoms.
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Statistical tests: Categorical variables will be expressed as a frequency and a percentage and compared with the chi-square test and the Fisher exact test when necessary. Quantitative variables will be expressed as median and interquartile range or mean and standard deviation. Assessment of normality and equality of variances for continuous data will be performed using the Shapiro-Wilk test and the Levene test, respectively. Thereafter, continuous variables will be compared by a Student t-test, Mann-Whitney U test or Fisher-Pitman permutation test as necessary. Multivariable Cox regression was fitted to examine the dependence of infective endocarditis on RRTs (haemodialysis, CVC [external or tunnelled], arteriovenous fistula, arteriovenous graft, and kidney transplantation).
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Exclusion Criteria:
Incidence of infective endocarditis in end stage renal disease patients on hemodialysis
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.
Time frame: Baseline
Infective endocarditis complications
Secondary (subsidiary): Patients presented by infective endocarditis complications such as refractory heart failure, distal embolization, cerebral haemorrhage, pyrexia of unknown origin.
Time frame: Baseline
Plan to share: No
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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