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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05692089
• Other study ID #: Infective endocarditis in ESRD
• Status: Completed
• Start date: February 1, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 15, 2024
• Est. primary completion date: September 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis
• Kidney Diseases
• Kidney Failure, Chronic

Locations

Country	Name	City	State
Egypt	Faculty of Medicine-Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Bruun NE, Habib G, Thuny F, Sogaard P. Cardiac imaging in infectious endocarditis. Eur Heart J. 2014 Mar;35(10):624-32. doi: 10.1093/eurheartj/eht274. Epub 2013 Jul 30. Erratum In: Eur Heart J. 2014 Sep 7;35(34):2334. — View Citation

Chaudry MS, Carlson N, Gislason GH, Kamper AL, Rix M, Fowler VG Jr, Torp-Pedersen C, Bruun NE. Risk of Infective Endocarditis in Patients with End Stage Renal Disease. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1814-1822. doi: 10.2215/CJN.02320317. Epub 2017 Oct 3. — View Citation

Iung B, Rouzet F, Brochet E, Duval X. Cardiac Imaging of Infective Endocarditis, Echo and Beyond. Curr Infect Dis Rep. 2017 Feb;19(2):8. doi: 10.1007/s11908-017-0560-2. — View Citation

McCarthy JT, Steckelberg JM. Infective endocarditis in patients receiving long-term hemodialysis. Mayo Clin Proc. 2000 Oct;75(10):1008-14. doi: 10.4065/75.10.1008. — View Citation

Roidad N, Rhodes L, Warden B. A review of the American Heart Association revised guidelines for the prevention of infective endocarditis. W V Med J. 2010 May-Jun;106(3):12-5. No abstract available. — View Citation

Stevenson KB, Adcox MJ, Mallea MC, Narasimhan N, Wagnild JP. Standardized surveillance of hemodialysis vascular access infections: 18-month experience at an outpatient, multifacility hemodialysis center. Infect Control Hosp Epidemiol. 2000 Mar;21(3):200-3. doi: 10.1086/501744. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	Infective endocarditis complications	Secondary (subsidiary): Patients presented by infective endocarditis complications such as refractory heart failure, distal embolization, cerebral haemorrhage, pyrexia of unknown origin.	Baseline