NCT01755338

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DRUG	Methylprednisolone	Methylprednisolone 15mg/kg
DRUG	Placebo	Placebo

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2012-12-24
• Last updated: 2017-06-01

Locations

1 site across 1 country: Sweden