Clinical Outcomes and Host Immune Response in Vascular Graft and Endograft Infections

Aarhus University Hospital300 enrolled

Overview

ACHIEVE is a prospective observational cohort and biobank study of patients with suspected or diagnosed central vascular graft or endograft infection. The study also includes patients undergoing elective central vascular graft or endograft implantation and healthy blood donor controls. Participants undergo longitudinal clinical data collection and biospecimen sampling. The study aims to characterize clinical outcomes, host immune responses, inflammatory biomarkers, pathogen-related factors, and novel microbiological diagnostic methods, including microbial cell-free DNA sequencing, in vascular graft and endograft infections.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Vascular Graft Infection Vascular Endograft Infection Aortic Graft Infection

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older. * Able and willing to provide informed consent. * For the vascular graft or endograft infection group: suspected or diagnosed vascular graft or endograft infection in a central vascular prosthesis as determined by the treating clinicians. * For the elective vascular graft or endograft control group: planned central vascular graft or endograft implantation. * For the healthy blood donor control group: active blood donor registered at Aarhus University Hospital Blood Bank. * For the healthy blood donor control group: no current infection or other active disease. Exclusion Criteria: * For the elective vascular graft or endograft control group: surgery performed as an emergency procedure within 24 hours. * For the elective vascular graft or endograft control group: reoperation of a previously implanted vascular graft or endograft. * For the elective vascular graft or endograft control group: evidence suggestive of ongoing infection in the area of surgery. * Unable to provide informed consent.

Outcomes

Primary Outcomes

Percentage of peripheral blood myeloid-derived suppressor cells among live PBMCs at baseline

Percentage of live PBMCs identified as myeloid-derived suppressor cells by flow cytometry, compared between participants with vascular graft or endograft infection and elective vascular graft/endograft controls.

Time frame: At baseline/inclusion

Proportion of selected VGEI sampling events with clinically adjudicated mNGS positivity

Selected VGEI sampling events with final consensus sample-level mNGS result classified as positive divided by all selected VGEI sampling events within the predefined clinical sampling category.

Time frame: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years

Proportion of selected VGEI sampling events with clinically relevant paired blood culture positivity

Selected VGEI sampling events with clinically relevant positive paired blood culture divided by all selected VGEI sampling events within the predefined clinical sampling category.

Time frame: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years

Secondary Outcomes

Proportion of selected VGEI sampling events with additional clinically relevant mNGS yield

Selected VGEI sampling events with consensus sample-level mNGS positivity and negative paired blood culture divided by all selected VGEI sampling events within the predefined clinical sampling category.

Time frame: At each paired VGEI sampling event from inclusion through follow-up, up to 10 years

Clinical Outcomes and Host Immune Response in Vascular Graft and Endograft Infections

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts