Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement

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POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. 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Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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Brief Title

Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement

Official Title

Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement

Brief Summary

      The purpose of this study is to investigate if methylprednisolone is effective in reducing
      the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.

Detailed Description

      In a previous study we found that patients undergoing aortic valve surgery had elevated
      cerebrospinal inflammatory markers. In this study we aim to investigate if this inflammatory
      response can be reduced after treatment with steroids.

      30 patients will be randomized to intraoperative treatment with either placebo or
      methylprednisolone 15mg/kg. CSF and blood will be collected the day before and the day after
      surgery, analyzed for markers of inflammation (IL-6, IL-8), neuronal damage (S-100) and blood
      brain barrier function (alb).

Study Type

Interventional

Primary Outcome

Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb

Secondary Outcome

 Postoperative/intraoperative insulin demand

Condition

Aortic Stenosis

Intervention

Methylprednisolone

Study Arms / Comparison Groups

 Methylprednisolone
Description:  Methylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

30

Start Date

December 2012

Completion Date

February 2017

Primary Completion Date

February 2017

Eligibility Criteria

        Inclusion Criteria:

          -  elective aortic surgery +/- coronary artery bypass grafting (CABG)

        Exclusion Criteria:

          -  coagulopathy

          -  preoperative neurologic deficit

          -  uncontrolled hypertension

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Sven-Erik Ricksten, Professor, ,

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations

NCT ID

NCT01755338

Organization ID

2012-004232-37

Responsible Party

Principal Investigator

Study Sponsor

Sahlgrenska University Hospital, Sweden

Study Sponsor

Sven-Erik Ricksten, Professor, Study Chair, Sahlgrenska University Hospital, Sweden

Verification Date

May 2017