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

NCT ID: NCT05692089

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-01-15

Brief Summary

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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

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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.

Conditions

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Infective Endocarditis End Stage Renal Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Christin Nashaat Sedeek Aziz

Resident Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khaled Mohammed Ali, PhD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Faculty of Medicine-Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 28974524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28233189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23900698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11040848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10738990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21736149 (View on PubMed)

Other Identifiers

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Infective endocarditis in ESRD

Identifier Type: -

Identifier Source: org_study_id

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