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

Sahlgrenska University Hospital

Status: Completed

Conditions: Aortic Stenosis

Treatments: Drug: Methylprednisolone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01755338

2012-004232-37

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• coagulopathy
• preoperative neurologic deficit
• uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Methylprednisolone

Active Comparator group

Description:

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

Treatment:

Drug: Methylprednisolone

Placebo (NaCl)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo