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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedJune 1, 2017
May 1, 2017
4.2 years
December 18, 2012
May 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb
24h after surgery
Secondary Outcomes (1)
Postoperative/intraoperative insulin demand
24h after surgery
Study Arms (2)
Methylprednisolone
ACTIVE COMPARATORMethylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement
Placebo (NaCl)
PLACEBO COMPARATORPlacebo i.v., x1, intraoperative Aortic Valve Replacement
Interventions
Eligibility Criteria
You may qualify if:
- elective aortic surgery +/- coronary artery bypass grafting (CABG)
You may not qualify if:
- coagulopathy
- preoperative neurologic deficit
- uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sahlgrenska University Hospital
Gothenburg, VGR, 41345, Sweden
Related Publications (1)
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.
PMID: 30261896DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sven-Erik Ricksten, Professor
Sahlgrenska University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 18, 2012
First Posted
December 24, 2012
Study Start
December 1, 2012
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
June 1, 2017
Record last verified: 2017-05