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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
History of Changes
  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:

U.S. FDA Resources

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
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

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

ClinicalTrials.gov processed this record on May 19, 2013