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Preoperative Methylprednisolone in Endovascular Aortic Repair (POMEVAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00989729
First Posted: October 5, 2009
Last Update Posted: November 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Louise de la Motte, Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention
Abdominal Aortic Aneurysms Drug: Methylprednisolone Drug: Physiological Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Louise de la Motte, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Systemic inflammatory response syndrome - SIRS [ Time Frame: Within 5 postoperative days ]

Secondary Outcome Measures:
  • Length of postoperative hospital stay [ Time Frame: Until discharge ]
  • Interleukin 6 plasma level [ Time Frame: Within 5 postoperative days ]
  • Adverse events related to Methylprednisolone [ Time Frame: Within 5 postoperative days ]

Enrollment: 150
Study Start Date: October 2009
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methylprednisolone
75 patients will receive a single preoperative dosage of Methylprednisolone
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.
Placebo Comparator: Physiological Saline
75 patients will receive a single preoperative dosage of Physiological Saline
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989729


Locations
Denmark
Department of Vascular Surgery, Rigshospitalet 3111
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Louise de la Motte
Investigators
Principal Investigator: Louise de la Motte, MD Rigshospitalet, Denmark
  More Information

Publications:
Responsible Party: Louise de la Motte, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00989729     History of Changes
Other Study ID Numbers: EVAR-150-2009
EudraCT number 2009-013441-28
H-A-2009-043
First Submitted: October 2, 2009
First Posted: October 5, 2009
Last Update Posted: November 14, 2014
Last Verified: November 2014

Keywords provided by Louise de la Motte, Rigshospitalet, Denmark:
Endovascular Aortic Repair
Methylprednisolone
Systemic inflammatory response syndrome

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents