Back to resultsPreoperative Methylprednisolone in Endovascular Aortic Repair (POMEVAR)
Primary Purpose
Abdominal Aortic Aneurysms
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Methylprednisolone
Physiological Saline
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Aortic Aneurysms focused on measuring Endovascular Aortic Repair, Methylprednisolone, Systemic inflammatory response syndrome
Eligibility 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.
Sites / Locations
- Department of Vascular Surgery, Rigshospitalet 3111
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Methylprednisolone
Physiological Saline
Arm Description
75 patients will receive a single preoperative dosage of Methylprednisolone
75 patients will receive a single preoperative dosage of Physiological Saline
Outcomes
Primary Outcome Measures
Systemic inflammatory response syndrome - SIRS
Secondary Outcome Measures
Length of postoperative hospital stay
Interleukin 6 plasma level
Adverse events related to Methylprednisolone
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00989729
Brief Title
Preoperative Methylprednisolone in Endovascular Aortic Repair
Acronym
POMEVAR
Official Title
Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Louise de la Motte
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms
Keywords
Endovascular Aortic Repair, Methylprednisolone, Systemic inflammatory response syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
75 patients will receive a single preoperative dosage of Methylprednisolone
Arm Title
Physiological Saline
Arm Type
Placebo Comparator
Arm Description
75 patients will receive a single preoperative dosage of Physiological Saline
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Solu-Medrol, Pfizer.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Physiological Saline
Other Intervention Name(s)
Physiological Saline 9 mg/ml, Fresenius Kabi
Intervention Description
A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery
Primary Outcome Measure Information:
Title
Systemic inflammatory response syndrome - SIRS
Time Frame
Within 5 postoperative days
Secondary Outcome Measure Information:
Title
Length of postoperative hospital stay
Time Frame
Until discharge
Title
Interleukin 6 plasma level
Time Frame
Within 5 postoperative days
Title
Adverse events related to Methylprednisolone
Time Frame
Within 5 postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise de la Motte, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Vascular Surgery, Rigshospitalet 3111
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25115430
Citation
de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lonn 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.
Results Reference
result
Learn more about this trial
Preoperative Methylprednisolone in Endovascular Aortic Repair
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