Inflammation Clinical Trial
Official title:
The Impact of Genetic Variability on Perioperative Morbidity and Mortality. Substudy: Inflammatory Response in Patients Undergoing Aortic Valve Replacement.
Verified date | July 2015 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Observational |
The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical access route).
Status | Completed |
Enrollment | 101 |
Est. completion date | May 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Written informed consent - Severe aortic valve stenosis - Surgical aortic valve replacement - Transcatheter aortic valve implantation - No previous inflammatory condition Exclusion Criteria - Missing informed consent - Treatment with corticosteroids - Treatment with antibiotics |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. Anesthesiology and Pain Therapy | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L) | Perioperative period ending after 48 hours postoperatively | No | |
Secondary | Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10) | Perioperative period ending after 48 hours postoperatively | No | |
Secondary | In-hospital mortality | In-hospital treatment until discharge (7-10 days) | No |
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