Inflammatory response
Conditions
Interventions
None listed
Sponsors
Rijnstate Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Elective EVAR/EVAS - Ability and willingness to provide written informed consent - Age *50 years
Exclusion criteria
Exclusion criteria: - Complex EVAR or EVAS, including iliac branched and supra-renal repairs (pre-planned visceral chimneys, fenestrations or branches) - Ruptured or symptomatic AAA - Planned internal iliac artery embolization - Acute or chronic inflammatory illness (i.e. upper respiratory tract infection) - Active rheumatoid arthritis - Inflammatory bowel disease - Inflammatory and mycotic aneurysms - Planned associated surgical procedure (i.e. iliac conduit, femoral endarterectomy, etc.) - Previous aortic surgery (open or endovascular) - Untreated malignancy - Major surgery six weeks before EVAR/EVAS - Ongoing or recent immunosuppressive treatment, including corticosteroid use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in early post-operative and long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome, the rise in WBC and circulating cytokines (TNF-*, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin I, NT-pro-BNP, at specified time points up to 12 months after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines* concentrations. 2. Post-operative pyrexia, measured at 24 and 48 hours. 3. 30-day and 1-year morbidity, cardiac complications (including measures of troponin I, NT-proBNP, and (all-cause and cardiac) mortality, their relationship with the type of graft used and the inflammatory response, measured by cytokines* concentrations. | — |
Countries
Netherlands
Outcome results
None listed