Prosthetic Valve Sweing Ring Injection by Antiboitics Can... | NCT05455788

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

NCT05455788

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 13, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Prosthetic Valve Endocarditis

Interventions

Aminoglycoside

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Dec 15, 2023Estimated

First Submitted Date

Jul 1, 2022

First Submission Date that Met QC Criteria

Jul 9, 2022

First Posted Date

Jul 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2022

Last Update Posted Date

Jul 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing Cardiac valve replacement			Drug: Aminoglycoside

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aminoglycoside	Drug	injection of sewing ring of prosthetic valve with aminoglycoside	Patients undergoing Cardiac valve replacement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kareem A Hosny	Contact	01000401994		kojakkemo@gmail.com
Amr I Osman	Contact	01000433878		dr.amr-osman@outlook.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University	Recruiting	Asyut		21557	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000617	Aminoglycosides

Ancestor Terms

ID	Term
D006027	Glycosides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided