Preoperative Methylprednisolone in Endovascular Aortic Repair (POMEVAR)

Louise de la Motte

Status: Completed

Conditions: Abdominal Aortic Aneurysms

Treatments: Drug: Physiological Saline; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00989729

EudraCT number 2009-013441-28

H-A-2009-043

EVAR-150-2009

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Methylprednisolone

Active Comparator group

Description:

75 patients will receive a single preoperative dosage of Methylprednisolone

Treatment:

Drug: Methylprednisolone

Physiological Saline

Placebo Comparator group

Description:

75 patients will receive a single preoperative dosage of Physiological Saline

Treatment:

Drug: Physiological Saline