Aortic Stenosis
Conditions
Keywords
cerebrospinal fluid, inflammatory markers, heart surgery, neuronal damage, blood brain barrier
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).
Interventions
DRUGMethylprednisolone
Methylprednisolone 15mg/kg
DRUGPlacebo
Placebo
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* elective aortic surgery +/- coronary artery bypass grafting (CABG)
Exclusion criteria
* coagulopathy * preoperative neurologic deficit * uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb | 24h after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative/intraoperative insulin demand | 24h after surgery |
Countries
Sweden
Outcome results
None listed