Inflammatory Response in Aortic Valve Replacement

Completed

• Conditions: Aortic Valve Stenosis; Systemic Inflammatory Response Syndrome; Thoracic Surgery; Inflammation
• Interventions: Other: Whole blood analysis

• Registration Number: NCT02324140
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-24
• Primary Completion: 2015-03
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-13
• Last Update Posted: 2015-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minimized extracorporeal circulation	Whole blood analysis	Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the minimized extracorporeal circulation (MECC, group 1)
Transcatheter aortic valve implantation, transfemoral access	Whole blood analysis	Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transfemoral access route
Conventional extracorporeal circulation	Whole blood analysis	Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the conventional extracorporeal circulation (CECC, group 2)
Transcatheter aortic valve implantation, transapical access	Whole blood analysis	Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transapical access route

Primary Outcome Measures

Name	Time	Method
Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)	Perioperative period ending after 48 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	In-hospital treatment until discharge (7-10 days)
Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10)	Perioperative period ending after 48 hours postoperatively

Trial Locations

Locations (1)

Dep. Anesthesiology and Pain Therapy; 🇨🇭 Bern, Switzerland