Preoperative Methylprednisolone in Endovascular Aortic Repair

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00989729

Acronym

POMEVAR

Enrollment

150

Registered

2009-10-05

Start date

2009-10-31

Completion date

2013-04-30

Last updated

2014-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysms

Keywords

Endovascular Aortic Repair, Methylprednisolone, Systemic inflammatory response syndrome

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.

Interventions

DRUGMethylprednisolone

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.

DRUGPhysiological Saline

A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Systemic inflammatory response syndrome - SIRS	Within 5 postoperative days

Secondary

Measure	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026