Brief Title
Preoperative Methylprednisolone in Endovascular Aortic Repair
Official Title
Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial
Brief Summary
The purpose of this study is to attenuate the systemic inflammatory response after Endovascular repair of abdominal aortic aneurysms, by administration of a single preoperative dosage of Methylprednisolone.
Study Type
Interventional
Primary Outcome
Systemic inflammatory response syndrome - SIRS
Secondary Outcome
Length of postoperative hospital stay
Condition
Abdominal Aortic Aneurysms
Intervention
Methylprednisolone
Study Arms / Comparison Groups
Methylprednisolone
Description: 75 patients will receive a single preoperative dosage of Methylprednisolone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
150
Start Date
October 2009
Completion Date
April 2013
Primary Completion Date
January 2013
Eligibility Criteria
Inclusion Criteria: - Elective endovascular repair of an asymptomatic abdominal aortic aneurysm. - Informed signed consent Exclusion Criteria: - Positive HIV status, positive hepatitis B or C status - Immunoinflammatory disease - except topically treated skin disease and respiratory disease. - Glaucoma - Gastric or duodenal ulcer - Systemic fungal infection - Immunosuppressive treatment - Current treatment for cancer - Allergy towards contents of Solu-Medrol - Alcohol consumption: Men > 21 drinks and women > 14 drinks weekly - Pregnancy - Lack of informed signed consent - Patients where follow up is planned at other location than Rigshospitalet.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Louise de la Motte, MD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00989729
Organization ID
EVAR-150-2009
Secondary IDs
EudraCT number 2009-013441-28
Responsible Party
Sponsor-Investigator
Study Sponsor
Louise de la Motte
Study Sponsor
Louise de la Motte, MD, Principal Investigator, Rigshospitalet, Denmark
Verification Date
November 2014