Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
NCT ID: NCT01755338
Last Updated: 2017-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2012-12-31
2017-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Methylprednisolone
Methylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement
Methylprednisolone
Methylprednisolone 15mg/kg
Placebo (NaCl)
Placebo i.v., x1, intraoperative Aortic Valve Replacement
Placebo
Placebo
Interventions
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Methylprednisolone
Methylprednisolone 15mg/kg
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* preoperative neurologic deficit
* uncontrolled hypertension
18 Years
80 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Mattias Danielson
MD
Principal Investigators
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Sven-Erik Ricksten, Professor
Role: STUDY_CHAIR
Sahlgrenska University Hospital
Locations
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Sahlgrenska University Hospital
Gothenburg, VGR, Sweden
Countries
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References
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Danielson M, Reinsfelt B, Westerlind A, Zetterberg H, Blennow K, Ricksten SE. Effects of methylprednisolone on blood-brain barrier and cerebral inflammation in cardiac surgery-a randomized trial. J Neuroinflammation. 2018 Sep 27;15(1):283. doi: 10.1186/s12974-018-1318-y.
Other Identifiers
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2012-004232-37
Identifier Type: -
Identifier Source: org_study_id
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