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
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.
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 stayInterleukin 6 plasma level Adverse events related to Methylprednisolone
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Department of Vascular Surgery, Rigshospitalet 3111, Copenhagen 2100, Denmark
Additional Information
Starting date: October 2009
Last updated: November 12, 2014
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