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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01755338
First Posted: December 24, 2012
Last Update Posted: June 1, 2017
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.
Information provided by (Responsible Party):
Mattias Danielson, Sahlgrenska University Hospital, Sweden
  Purpose
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 Intervention
Aortic Stenosis Drug: Methylprednisolone Drug: Placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mattias Danielson, Sahlgrenska University Hospital, Sweden:

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 ]

Enrollment: 30
Study Start Date: December 2012
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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 ClinicalTrials.gov identifier (NCT number): NCT01755338


Locations
Sweden
Sahlgrenska University Hospital
Göteborg, VGR, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Study Chair: Sven-Erik Ricksten, Professor Sahlgrenska University Hospital, Sweden
  More Information

Responsible Party: Mattias Danielson, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01755338     History of Changes
Other Study ID Numbers: 2012-004232-37
First Submitted: December 18, 2012
First Posted: December 24, 2012
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:
Inflammation
Aortic Valve Stenosis
Pathologic Processes
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
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