Preoperative Methylprednisolone in Endovascular Aortic Repair (POMEVAR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Louise de la Motte, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00989729
First received: October 2, 2009
Last updated: February 18, 2013
Last verified: February 2013

October 2, 2009
February 18, 2013
October 2009
January 2013   (final data collection date for primary outcome measure)
Systemic inflammatory response syndrome - SIRS [ Time Frame: Within 5 postoperative days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00989729 on ClinicalTrials.gov Archive Site
  • Length of postoperative hospital stay [ Time Frame: Until discharge ] [ Designated as safety issue: No ]
  • Interleukin 6 plasma level [ Time Frame: Within 5 postoperative days ] [ Designated as safety issue: No ]
  • Adverse events related to Methylprednisolone [ Time Frame: Within 5 postoperative days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Preoperative Methylprednisolone in Endovascular Aortic Repair
Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Abdominal Aortic Aneurysms
  • 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.
    Other Name: Solu-Medrol, Pfizer.
  • Drug: Physiological Saline
    A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery
    Other Name: Physiological Saline 9 mg/ml, Fresenius Kabi
  • Active Comparator: Methylprednisolone
    75 patients will receive a single preoperative dosage of Methylprednisolone
    Intervention: Drug: Methylprednisolone
  • Placebo Comparator: Physiological Saline
    75 patients will receive a single preoperative dosage of Physiological Saline
    Intervention: Drug: Physiological Saline
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 Surg. 2014 Sep;260(3):540-8; discussion 548-9. doi: 10.1097/SLA.0000000000000895.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
April 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00989729
EVAR-150-2009, EudraCT number 2009-013441-28, H-A-2009-043
Yes
Louise de la Motte, Rigshospitalet, Denmark
Louise de la Motte
Not Provided
Principal Investigator: Louise de la Motte, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP