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

Completed

• Conditions: End Stage Renal Disease; Infective Endocarditis

• Registration Number: NCT05692089
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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or a possible vegetation without any evidence of regurgitation. 3 sets of blood culture with one hour interval will be withdrawn from the central line from all patients, before stating antibiotics within 24 hours from the onset of symptoms.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Study Start: 2023-02-01
• Primary Completion: 2023-09-03
• Status Verified: 2024-01
• Study Completion: 2024-01-15
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of infective endocarditis in end stage renal disease patients on hemodialysis	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.

Secondary Outcome Measures

Name	Time	Method
Infective endocarditis complications	Baseline	Secondary (subsidiary): Patients presented by infective endocarditis complications such as refractory heart failure, distal embolization, cerebral haemorrhage, pyrexia of unknown origin.

Trial Locations

Locations (1)

Faculty of Medicine-Assiut University; 🇪🇬 Assiut, Egypt