Clinical Outcomes and Host Immune Response in Vascular Graft and Endograft Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Study participants will be selected from clinical populations in the Central Denmark Region. Patients with suspected or diagnosed central vascular graft or endograft infection will be identified through infectious diseases and vascular/cardiothoracic surgical clinical care pathways, electronic medical records, and local departmental databases. Elective vascular graft/endograft control participants will be identified through the preoperative surgical pathway. Healthy blood donor controls will be selected from the Aarhus University Hospital Blood Bank during routine blood donation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: Case group
Group B: Control group
Group C: Healthy Blood Donors
Trial outcomes
Primary outcomes
1
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/inclusion2
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 years3
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 yearsSecondary outcomes
1
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 yearsOther outcomes
1
Distribution of microbiological pathogens identified in VGEI participants
Type of microorganism identified by conventional microbiology from blood, perioperative specimens, operative wounds, graft/perigraft material, or other clinically relevant foci in enrolled VGEI participants.
Time frame
From inclusion through follow-up, up to 10 yearsSponsors and contacts
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Aarhus University Hospital
Lead sponsor
Aalborg University
Collaborator
Central Denmark Region
Collaborator
Randers Regional Hospital
Collaborator
Gødstrup Hospital
Collaborator
Regionshospitalet Horsens
Collaborator
University of Aarhus
Collaborator
Viborg Regional Hospital
Collaborator
Source ClinicalTrials.gov