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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755338
• Other study ID #: 2012-004232-37
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: May 31, 2017
• Start date: December 2012
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• coagulopathy

• preoperative neurologic deficit

• uncontrolled hypertension

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Inflammation

Intervention

Drug:
• Methylprednisolone
Methylprednisolone 15mg/kg
• Placebo
Placebo

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg	VGR

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb		24h after surgery
Secondary	Postoperative/intraoperative insulin demand		24h after surgery