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