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Completed

NCT Number: NCT00989729

Preoperative Methylprednisolone in Endovascular Aortic Repair

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.

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Key information

Conditions

Abdominal Aortic Aneurysms Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Vascular Surgery, Rigshospitalet 3111

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methylprednisolone

Drug

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 names: Solu-Medrol, Pfizer.

physiological saline

Drug

A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery

Other names: Physiological Saline 9 mg/ml, Fresenius Kabi

Primary outcomes

  1. Systemic inflammatory response syndrome - SIRS

    Time frame: Within 5 postoperative days

Secondary outcomes

  1. Length of postoperative hospital stay

    Time frame: Until discharge

  2. Interleukin 6 plasma level

    Time frame: Within 5 postoperative days

  3. Adverse events related to Methylprednisolone

    Time frame: Within 5 postoperative days

Sponsors and collaborators

Lead sponsor

Louise de la Motte

Other

Registry information

Official study title

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

Acronym: POMEVAR

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 5, 2009
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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