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Recruiting NCT06866535

VIP - Vascular Infection Project

Observational Aortitis Vascular Graft Infection Blood Vessel Prosthesis Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aortitis, Vascular Graft Infection, Blood Vessel Prosthesis, Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

VIP - Vascular Infection Project : Prospective Multicentric Database on Vascular Infections

Overview

Constitution of a prospective multicentric observational database to study vascular infections, both native, especially aortitis, and vascular graft and endograft infections. Clinical and paraclinical data on medical, surgical, anesthetic and intensive care management will be collected in order to better characterize these infections

Detailed description

Vascular infections are rare but severe, burdened by high morbi-mortality and recurrence rates. However, many questions remain regarding their management which is still not consensual, both surgical and medical management. The term "vascular infections" encompasses vascular graft and endograft infections, as well as infections of native arteries and the aorta. For vascular graft infections, the optimal surgery is to remove the infected graft before vascular reconstruction with a new graft, either synthetic or biologic. However, some patients are too fragile to undergo surgery and might then benefit from an endovascular graft, an abscess drainage or no surgery at all, only medical treatment. For native arterial infections, surgery is often required to remove the infected arterial wall before vascular reconstruction. However, some patients cannot be operated on and might also benefit from an endovascular surgery. In these two vascular infections, the ideal anti-microbial treatment is uncertain, whether it pertains to the duration of therapy, the type of molecules, or their number. All of these medical and surgical factors may impact the prognosis of patients and should be collectively assessed in order to determine the best strategy for enhancing their outcomes.

Primary outcome measures

  • mortality [Time frame: Year 1]
Secondary outcome measures (4)
  • mortality [Time frame: Day 30, Year 2, Year 5]
  • morbidity [Time frame: Year 1]
  • relapse [Time frame: year 1, Year 2, Year 5]
  • reinfection [Time frame: year 1, Year 2, Year 5]

Eligibility criteria

Inclusion criteria

  • ≥ 18 years-old;
  • all patients with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent),
  • oral consent

Exclusion criteria

  • patient under legal protection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU Bordeaux — Bordeaux

Identifiers

NCT: NCT06866535 · CHUBX 2022/01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗