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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2009-013441-28 | |||
| H-A-2009-043 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Active Comparator | 75 patients will receive a single preoperative dosage of Methylprednisolone |
|
| Physiological Saline | Placebo Comparator | 75 patients will receive a single preoperative dosage of Physiological Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic inflammatory response syndrome - SIRS | Within 5 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of postoperative hospital stay | Until discharge | |
| Interleukin 6 plasma level | Within 5 postoperative days | |
| Adverse events related to Methylprednisolone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise de la Motte, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Surgery, Rigshospitalet 3111 | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25115430 | Result | de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lonn L. Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial. Ann Surg. 2014 Sep;260(3):540-8; discussion 548-9. doi: 10.1097/SLA.0000000000000895. |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Physiological Saline | Drug | A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery |
|
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| Within 5 postoperative days |
| D001018 |
| Aortic Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |