An interventional study of Methylprednisolone and Placebo in Aortic Stenosis, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment
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.
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).
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 30 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Methylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement
Drug: Methylprednisolone
Placebo i.v., x1, intraoperative Aortic Valve Replacement
Drug: Placebo
Methylprednisolone 15mg/kg
Also known as: Solu-Medrol
Placebo
Also known as: Sodium Chloride
Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb
Time frame: 24h after surgery
Postoperative/intraoperative insulin demand
Time frame: 24h after surgery
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Sahlgrenska University Hospital