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Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01755338
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
Mattias Danielson, 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.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Drug: Methylprednisolone Drug: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
Study Start Date : December 2012
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Active Comparator: Methylprednisolone
Methylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement
Drug: Methylprednisolone
Methylprednisolone 15mg/kg
Other Name: Solu-Medrol

Placebo Comparator: Placebo (NaCl)
Placebo i.v., x1, intraoperative Aortic Valve Replacement
Drug: Placebo
Other Name: Sodium Chloride

Primary Outcome Measures :
  1. Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb [ Time Frame: 24h after surgery ]

Secondary Outcome Measures :
  1. Postoperative/intraoperative insulin demand [ Time Frame: 24h after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • elective aortic surgery +/- coronary artery bypass grafting (CABG)

Exclusion Criteria:

  • coagulopathy
  • preoperative neurologic deficit
  • uncontrolled hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01755338

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Sahlgrenska University Hospital
Göteborg, VGR, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
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Study Chair: Sven-Erik Ricksten, Professor Sahlgrenska University Hospital, Sweden
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mattias Danielson, MD, Sahlgrenska University Hospital, Sweden Identifier: NCT01755338    
Other Study ID Numbers: 2012-004232-37
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Keywords provided by Mattias Danielson, Sahlgrenska University Hospital, Sweden:
cerebrospinal fluid
inflammatory markers
heart surgery
neuronal damage
blood brain barrier
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Pathologic Processes
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents