Preoperative Methylprednisolone in Endovascular Aortic Repair

Abdominal Aortic Aneurysms Clinical Trial

— POMEVAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989729
• Other study ID #: EVAR-150-2009
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: N/A
• First received: October 2, 2009
• Last updated: November 12, 2014
• Start date: October 2009
• Est. completion date: April 2013

Study information

• Verified date: November 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Drug:
• Methylprednisolone
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.
• Physiological Saline
A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery

Locations

Country	Name	City	State
Denmark	Department of Vascular Surgery, Rigshospitalet 3111	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Louise de la Motte

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lönn L. Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial. Ann — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic inflammatory response syndrome - SIRS		Within 5 postoperative days	No
Secondary	Length of postoperative hospital stay		Until discharge	No
Secondary	Interleukin 6 plasma level		Within 5 postoperative days	No
Secondary	Adverse events related to Methylprednisolone		Within 5 postoperative days	Yes