Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?

July 9, 2022 updated by: Amr Ibrahim Osman, Assiut University
Follow-up of patients undergoing cardiac valve replacements with prosthetic valve after injection of sewing ring of prosthetic valve with aminoglycoside for prevention of infective endocarditis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 21557
        • Recruiting
        • Assiut University
        • Contact:

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed with heart valve disease and indicated for valve replacement.

Description

Inclusion Criteria:

  • patients who need cardiac valve replacement for rheumatic or degenerative causes

Exclusion Criteria:

  • Patients undergoing open heart surgery for any cause other than valve replacement
  • patients who are younger than 20 years old.
  • Patients undergoing valve repair.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing Cardiac valve replacement
Drug: Aminoglycoside
injection of sewing ring of prosthetic valve with aminoglycoside

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients diagnosed with Infective endocarditis post valve replacement
Time Frame: 6 months post operative
percentage of post operative clinical and echocardiographic diagnosis of infective endocarditis on prosthetic valve
6 months post operative

Collaborators and Investigators

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

Sponsor

Assiut University

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)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 15, 2023

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 9, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 9, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutMedic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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