Abdominal Aortic AneurysmsPOMEVARNCT00989729
Preoperative Methylprednisolone in Endovascular Aortic Repair
A study testing Methylprednisolone and Physiological Saline in people with Abdominal Aortic Aneurysms, run by Louise de la Motte at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- Methylprednisolone and Physiological Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective endovascular repair of an asymptomatic abdominal aortic aneurysm.
- Informed signed consent
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Vascular Surgery, Rigshospitalet 3111
Copenhagen, 2100
About this study
Official title: Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial
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.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- Methylprednisolone, Physiological Saline
- Keywords
- Endovascular Aortic Repair, Methylprednisolone, Systemic inflammatory response syndrome
- Medical subject headings
- Aortic Aneurysm, Abdominal, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Solu-Medrol, Pfizer.
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 SalineDrug
Also called Physiological Saline 9 mg/ml, Fresenius Kabi
A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | 75 patients will receive a single preoperative dosage of Methylprednisolone Receives: Drug: Methylprednisolone |
| Physiological Saline | Placebo comparator | 75 patients will receive a single preoperative dosage of Physiological Saline Receives: Drug: Physiological Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic inflammatory response syndrome - SIRS
Measured: Within 5 postoperative days
Secondary outcomes (3)
Length of postoperative hospital stay
Measured: Until discharge
Interleukin 6 plasma level
Measured: Within 5 postoperative days
Adverse events related to Methylprednisolone
Measured: Within 5 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louise de la Motte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Louise de la Motte, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Louise de la Motte, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989729
- Sponsor's protocol ID
- EVAR-150-2009
- Other IDs
- EudraCT number 2009-013441-28, H-A-2009-043
- Acronym
- POMEVAR
- Status last verified
- Nov 2014
- First submitted
- 2 Oct 2009
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25115430
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00989729
- Acronym / sponsor ID
- POMEVAR / EVAR-150-2009
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Endovascular Aortic Repair, Methylprednisolone, Systemic inflammatory response syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Louise de la MotteUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: Methylprednisolone75 patients will receive a single preoperative dosage of Methylprednisolone |
| Physiological Saline | Placebo comparator | Drug: Physiological Saline75 patients will receive a single preoperative dosage of Physiological Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective endovascular repair of an asymptomatic abdominal aortic aneurysm.
- Informed signed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneAlso: Solu-Medrol, Pfizer.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. | Drug | Methylprednisolone |
| Physiological SalineAlso: Physiological Saline 9 mg/ml, Fresenius KabiA single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery | Drug | Physiological Saline |
Primary outcome
Systemic inflammatory response syndrome - SIRS
Time frame: Within 5 postoperative days
3 secondary outcomes
Length of postoperative hospital stay
Time frame: Until discharge
Interleukin 6 plasma level
Time frame: Within 5 postoperative days
Adverse events related to Methylprednisolone
Time frame: Within 5 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
- Results publication: PubMed 25115430de 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.
Related trials for Abdominal Aortic Aneurysms
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise de la Motte, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylprednisolone and Physiological Saline in people with Abdominal Aortic Aneurysms, run by Louise de la Motte at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic inflammatory response syndrome - SIRS (time frame: Within 5 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00989729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.