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Preoperative Methylprednisolone in Endovascular Aortic Repair

Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abdominal Aortic Aneurysms

Intervention: Methylprednisolone (Drug); Physiological Saline (Drug)

Phase: N/A

Status: Completed

Sponsored by: Louise de la Motte

Official(s) and/or principal investigator(s):
Louise de la Motte, MD, Principal Investigator, Affiliation: Rigshospitalet, Denmark


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.

Clinical Details

Official title: Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Systemic inflammatory response syndrome - SIRS

Secondary outcome:

Length of postoperative hospital stay

Interleukin 6 plasma level

Adverse events related to Methylprednisolone


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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.

Locations and Contacts

Department of Vascular Surgery, Rigshospitalet 3111, Copenhagen 2100, Denmark
Additional Information

Starting date: October 2009
Last updated: November 12, 2014

Page last updated: August 23, 2015

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