Infective EndocarditisNCT05692089
Incidence of Infective Endocarditis in End Stage Renal Disease Patients on Hemodialysis by Transesophageal Echocardiography in Assuit University Hospital
An observational study of Infective Endocarditis and End Stage Renal Disease, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infective Endocarditis, End Stage Renal Disease
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Incidence of infective endocarditis in ESRD that on hemodialysis.
- Must be fit for Transoesophageal ECHO.
Who cannot join
- Any patient with sepsis due to causes other than infected vascular access.
Trial locations and contacts
1 site in 1 country.
About this study
- To detect in more detail the incidence of infective endocarditis in patients with end stage renal disease (ESRD) on hemodialysis.
- To compare the relationship between different forms of haemodialysis access type and the related incidence of infective endocarditis.
- To determine individual risk factors, including type of vascular haemodialysis access, previous valve lesion and immunocompromised patients.
Read the 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.
- Conditions
- Infective Endocarditis, End Stage Renal Disease
- Medical subject headings
- Endocarditis, Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Infective endocarditis complications
Secondary (subsidiary): Patients presented by infective endocarditis complications such as refractory heart failure, distal embolization, cerebral haemorrhage, pyrexia of unknown origin.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Feb 2023
- Primary completion3 Sep 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christin Nashaat Sedeek Aziz, Assiut University
- Investigators
- Khaled Mohammed Ali, PhD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692089
- Sponsor's protocol ID
- Infective endocarditis in ESRD
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 28974524Iung 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.
PubMed 28233189Bruun 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.
PubMed 23900698McCarthy 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.
PubMed 11040848Stevenson 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.
PubMed 10738990Roidad 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.
PubMed 21736149
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Infective Endocarditis in End Stage Renal Disease Patients on Hemodialysis by Transesophageal Echocardiography in Assuit University Hospital
- ClinicalTrials.gov ID
- NCT05692089
- Acronym / sponsor ID
- Infective endocarditis in ESRD
- Conditions
- Infective Endocarditis, End Stage Renal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 3 Sep 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To detect in more detail the incidence of infective endocarditis in patients with end stage renal disease (ESRD) on hemodialysis.
- To compare the relationship between different forms of haemodialysis access type and the related incidence of infective endocarditis.
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Incidence of infective endocarditis in ESRD that on hemodialysis.
- Must be fit for Transoesophageal ECHO.
Key exclusion criteria (1 listed)
- Any patient with sepsis due to causes other than infected vascular access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Infective endocarditis complications
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 28974524Chaudry 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.
- Background: PubMed 28233189Iung 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.
- Background: PubMed 23900698Bruun 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.
- Background: PubMed 11040848McCarthy 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.
- Background: PubMed 10738990Stevenson 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.
- Background: PubMed 21736149Roidad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled Mohammed Ali, PhD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis and End Stage Renal Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infective endocarditis in end stage renal disease patients on hemodialysis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05692089, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.