Preoperative Methylprednisolone in Endovascular Aortic Repair

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysms
• Interventions: Drug: Physiological Saline; Drug: Methylprednisolone

• Registration Number: NCT00989729
• Lead Sponsor: Louise de la Motte

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-05
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-12
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiological Saline	Physiological Saline	75 patients will receive a single preoperative dosage of Physiological Saline
Methylprednisolone	Methylprednisolone	75 patients will receive a single preoperative dosage of Methylprednisolone

Primary Outcome Measures

Name	Time	Method
Systemic inflammatory response syndrome - SIRS	Within 5 postoperative days

Secondary Outcome Measures

Name	Time	Method
Length of postoperative hospital stay	Until discharge
Interleukin 6 plasma level	Within 5 postoperative days
Adverse events related to Methylprednisolone	Within 5 postoperative days

Trial Locations

Locations (1)

Department of Vascular Surgery, Rigshospitalet 3111; 🇩🇰 Copenhagen, Denmark