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

Primary Purpose

Aortic Stenosis

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Methylprednisolone

Placebo

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring cerebrospinal fluid, inflammatory markers, heart surgery, neuronal damage, blood brain barrier

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

coagulopathy
preoperative neurologic deficit
uncontrolled hypertension

Sites / Locations

Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylprednisolone

Placebo (NaCl)

Arm Description

Methylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement

Placebo i.v., x1, intraoperative Aortic Valve Replacement

Outcomes

Primary Outcome Measures

Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb

Secondary Outcome Measures

Postoperative/intraoperative insulin demand

Full Information

NCT ID

NCT01755338

First Posted

December 18, 2012

Last Updated

May 31, 2017

Sponsor

Sahlgrenska University Hospital, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT01755338

Brief Title

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

Official Title

Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Stenosis

Keywords

cerebrospinal fluid, inflammatory markers, heart surgery, neuronal damage, blood brain barrier

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methylprednisolone

Arm Type

Active Comparator

Arm Description

Methylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement

Arm Title

Placebo (NaCl)

Arm Type

Placebo Comparator

Arm Description

Placebo i.v., x1, intraoperative Aortic Valve Replacement

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Other Intervention Name(s)

Solu-Medrol

Intervention Description

Methylprednisolone 15mg/kg

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sodium Chloride

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb

Time Frame

24h after surgery

Secondary Outcome Measure Information:

Title

Postoperative/intraoperative insulin demand

Time Frame

24h after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: elective aortic surgery +/- coronary artery bypass grafting (CABG) Exclusion Criteria: coagulopathy preoperative neurologic deficit uncontrolled hypertension

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sven-Erik Ricksten, Professor

Organizational Affiliation

Sahlgrenska University Hospital, Sweden

Official's Role

Study Chair

Facility Information:

Facility Name

Sahlgrenska University Hospital

City

Göteborg

State/Province

VGR

ZIP/Postal Code

41345

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

30261896

Citation

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.

Results Reference

derived

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

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