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Completed

NCT Number: NCT01755338

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

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, VGR, 41345, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • coagulopathy
  • preoperative neurologic deficit
  • uncontrolled hypertension

Treatment and study plan

methylprednisolone

Drug

Methylprednisolone 15mg/kg

Other names: Solu-Medrol

Placebo

Drug

Placebo

Other names: Sodium Chloride

Primary outcomes

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

    Time frame: 24h after surgery

Secondary outcomes

  1. Postoperative/intraoperative insulin demand

    Time frame: 24h after surgery

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2012
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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