Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
- Registration Number
- NCT01755338
- Lead Sponsor
- Sahlgrenska University Hospital, Sweden
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- elective aortic surgery +/- coronary artery bypass grafting (CABG)
- coagulopathy
- preoperative neurologic deficit
- uncontrolled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methylprednisolone Methylprednisolone Methylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement Placebo (NaCl) Placebo Placebo i.v., x1, intraoperative Aortic Valve Replacement
- Primary Outcome Measures
Name Time Method Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb 24h after surgery
- Secondary Outcome Measures
Name Time Method Postoperative/intraoperative insulin demand 24h after surgery
Trial Locations
- Locations (1)
Sahlgrenska University Hospital
🇸🇪Göteborg, VGR, Sweden