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Preoperative Methylprednisolone in Endovascular Aortic Repair

NCT ID: NCT00989729

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Abdominal Aortic Aneurysms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methylprednisolone

75 patients will receive a single preoperative dosage of Methylprednisolone

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type 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.

Physiological Saline

75 patients will receive a single preoperative dosage of Physiological Saline

Group Type PLACEBO_COMPARATOR

Physiological Saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Physiological Saline

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

Intervention Type DRUG

Other Intervention Names

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Solu-Medrol, Pfizer. Physiological Saline 9 mg/ml, Fresenius Kabi

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Louise de la Motte

OTHER

Sponsor Role lead

Responsible Party

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Louise de la Motte

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Louise de la Motte, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Department of Vascular Surgery, Rigshospitalet 3111

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 25115430 (View on PubMed)

Other Identifiers

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EudraCT number 2009-013441-28

Identifier Type: -

Identifier Source: secondary_id

H-A-2009-043

Identifier Type: -

Identifier Source: secondary_id

EVAR-150-2009

Identifier Type: -

Identifier Source: org_study_id