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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Systemic inflammatory response syndrome - SIRS [ Time Frame: Within 5 postoperative days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: October 2009
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: October 2, 2009
Last Updated: February 18, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Endovascular Aortic Repair
Methylprednisolone
Systemic inflammatory response syndrome

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

ClinicalTrials.gov processed this record on October 30, 2014