Risk and Incidence of Aortic Graft and Endograft Infectio... | NCT05521035

Studies
Risk and Incidence of Aortic Graft and Endograft Infection With BSI

NCT05521035

Sponsor

Lund University

Status

Unknown status

Last Update Posted

Dec 14, 2023Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Aortic Infections and Inflammations

Interventions

Not provided

Countries

Sweden

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

Dec 2023

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

Sep 1, 2022Actual

Primary Completion Date

Sep 1, 2024Estimated

Completion Date

Sep 1, 2024Estimated

First Submitted Date

Aug 26, 2022

First Submission Date that Met QC Criteria

Aug 26, 2022

First Posted Date

Aug 30, 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

Dec 11, 2023

Last Update Posted Date

Dec 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

What is the risk of aortic vascular graft and endograft infection in patients with aortic vascular graft/endograft and bloodstream infection?

Detailed Description

All patients with previous aortic vascular graft and endograft surgery between years 2010 and 2021 in four regions of south Sweden (Skåne, Halland, Kronoberg and Blekinge) will be included in the study. These patients will be evaluated for bloodstream infection (BSI) or not. For all patients with BSI, the risk of aortic vascular graft and endograft infection will be investigated. Aortic vascular graft and endograft infection will be determined by usage of the MAGIC-criteria.

Risk factors for developing aortic vascular graft and endograft infection will be investigated, and if possible used to construct a risk score. This risk score could be used by clinicians to determine if bacteremic patients with aortic vascular grafts or endografts should be evaluated for aortic vascular graft and endograft infection.

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

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aortic vascular graft or endograft infection	Determined by the MAGIC-criteria	At least 1 year follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previous aortic vascular graft or endograft infection with bloodstream infection.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with previous aortic vascular graft or endograft surgery in Skåne, Halland, Kronoberg and Blekinge between the years 2010-2021.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oskar Ljungquist, M.D, PhD	Contact	+46424061000		oskar.ljungquist@med.lu.se
Torgny Sunnerhagen, M.D, PhD	Contact			torgny.sunnerhagen@med.lu.se

Overall Officials

Name	Affiliation	Role
Oskar Ljungquist	Lund University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsingborgs lasarett	Recruiting	Helsingborg			Sweden

References Module

Citations

Not provided

Label	URL
Treatment and outcomes of aortic endograft infection	View source
Diagnosis of Aortic Graft Infection: A Case Definition by the Management of Aortic Graft Infection Collaboration (MAGIC)	View source
Secondary infections of thoracic and abdominal aortic endografts

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms