Clinical trial NCT02324140: Inflammatory Response in Aortic Valve Replacement
Official title: The Impact of Genetic Variability on Perioperative Morbidity and Mortality. Substudy: Inflammatory Response in Patients Undergoing Aortic Valve Replacement.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Systemic Inflammatory Response Syndrome
Thoracic Surgery
Aortic Valve Stenosis
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe aortic valve stenosis selected for surgical aortic valve replacement or transcatheter aortic valve implantation.

Brief summary: 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).

Detailed description: Background

Surgical and interventional therapy for aortic valve stenosis exposes the patients to a immune reaction, which is different depending on the type of the treatment. In this study, the investigators would like to better understand the inflammatory and antiinflammatory response in this patient population by monitoring the perioperative cytokine response (interleukins), the human leukocyte antigen expression (HLA-DR) and assessing soluble plasma factors (CD62L) involved in inflammatory processes.

Objective

Characterisation of inflammatory and antiinflammatory response in patients receiving aortic valve prosthesis selected for different treatment options.

Methods

Whole blood analysis at different time points (preoperatively, 4 / 24 /48 hours postoperatively) for different inflammatory and antiinflammatory markers: IL-6, IL-8, IL-10, CRP, TNF, soluble CD62L.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)
timeFrame: Perioperative period ending after 48 hours postoperatively
Secondary outcomes:
measure: Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10)
timeFrame: Perioperative period ending after 48 hours postoperatively
measure: In-hospital mortality
timeFrame: In-hospital treatment until discharge (7-10 days)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. Anesthesiology and Pain Therapy
Study officials:
affiliation: Dep. Anesthesiology and pain Therapy
name: Frank Stüber, MD, Prof.
role: STUDY_DIRECTOR
References: