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

January 29, 2024 updated by: Christin Nashaat Sedeek Aziz, Assiut University
  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.

Study Overview

Status

Completed

Conditions

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or a possible vegetation without any evidence of regurgitation. 3 sets of blood culture with one hour interval will be withdrawn from the central line from all patients, before stating antibiotics within 24 hours from the onset of symptoms.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

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71516
        • Faculty of Medicine-Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of infective endocarditis in end stage renal disease patients on hemodialysis
Time Frame: 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.
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Khaled Mohammed Ali, PhD, Assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

September 3, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Infective endocarditis in ESRD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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