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

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ClinicalTrials.gov Identifier: NCT01755338

Recruitment Status : Completed

First Posted : December 24, 2012

Last Update Posted : June 1, 2017

Sponsor:

Information provided by (Responsible Party):

Mattias Danielson, Sahlgrenska University Hospital, Sweden

Study Description

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).

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Supravalvular aortic stenosis

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis

U.S. FDA Resources

Arms and Interventions

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 Placebo Other Name: Sodium Chloride

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Postoperative/intraoperative insulin demand [ Time Frame: 24h after surgery ]

Eligibility Criteria

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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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

coagulopathy
preoperative neurologic deficit
uncontrolled hypertension

Contacts and Locations

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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 ClinicalTrials.gov identifier (NCT number): NCT01755338

Locations

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Sweden
Sahlgrenska University Hospital
Göteborg, VGR, Sweden, 41345

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

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Study Chair:	Sven-Erik Ricksten, Professor	Sahlgrenska University Hospital, Sweden

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Mattias Danielson, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov 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 Inflammation Pathologic Processes Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate	Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Protective Agents Antineoplastic Agents, Hormonal Antineoplastic Agents

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