Preoperative Methylprednisolone in Endovascular Aortic Repair

Study Overview
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Brief Summary
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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.

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

Conditions
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Abdominal Aortic Aneurysms

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Physiological Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylprednisolone<br>75 patients will receive a single preoperative dosage of Methylprednisolone | Drug: Methylprednisolone<br>* A single preoperative dosage 30 mg/kg Methylprednisolone suspended in physiological saline (100 ml in total) given intravenously as a 30 minute infusion, 2 hours before surgery.<br>* Other names: Solu-Medrol, Pfizer.;|
| Placebo Comparator: Physiological Saline<br>75 patients will receive a single preoperative dosage of Physiological Saline | Drug: Physiological Saline<br>* A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery<br>* Other names: Physiological Saline 9 mg/ml, Fresenius Kabi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic inflammatory response syndrome - SIRS |  | Within 5 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of postoperative hospital stay |  | Until discharge | 
| Interleukin 6 plasma level |  | Within 5 postoperative days | 
| Adverse events related to Methylprednisolone |  | Within 5 postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endovascular Aortic Repair, Methylprednisolone, Systemic inflammatory response syndrome