Inflammatory Response in Aortic Valve Replacement

July 13, 2015 updated by: University Hospital Inselspital, Berne

The Impact of Genetic Variability on Perioperative Morbidity and Mortality. Substudy: Inflammatory Response in Patients Undergoing Aortic Valve Replacement.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Dep. Anesthesiology and Pain Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with severe aortic valve stenosis selected for surgical aortic valve replacement or transcatheter aortic valve implantation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Minimized extracorporeal circulation
Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the minimized extracorporeal circulation (MECC, group 1)
Other: Whole blood analysis
In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
Conventional extracorporeal circulation
Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the conventional extracorporeal circulation (CECC, group 2)
Other: Whole blood analysis
In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
Transcatheter aortic valve implantation, transfemoral access
Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transfemoral access route
Other: Whole blood analysis
In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
Transcatheter aortic valve implantation, transapical access
Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transapical access route
Other: Whole blood analysis
In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Study Director: Frank Stüber, MD, Prof., Dep. Anesthesiology and Pain Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

December 15, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (ESTIMATE)

December 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 041/09_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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