Aortic AneurysmNCT05054972
Left Renal Vein Division for Juxtarenal Aortic Exposure
An observational study of Aortic Aneurysm and Juxtarenal Aortic Aneurysm, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Retrospective study on the outcome of the renal function in patients operated because of juxtarenal aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Aneurysm, Juxtarenal Aortic Aneurysm, Renal Function Disorder
- What is being tested?
- Exclusion of the aortic aneurysm.
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2020to 30 Dec 2021
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were treated surgically for a juxtrarenal aortic aneurysm with an open operation.
Who may be able to join
- Only patients who went for a planned operation because of a juxtarenal aortic aneurysm were included in this retrospective analysis.
Who cannot join
- Emergency surgery Rupture Pending rupture
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Vascular Surgery, Medical University of Vienna
Vienna
About this study
Official title: Left Renal Vein Division for Juxtarenal Aortic Exposure: Renal Function and Role of the Communicating Lumbar Vein
Retrospective study on the outcome of the renal function in patients operated because of juxtarenal aortic aneurysms.
- Being tested
- Exclusion of the aortic aneurysm.
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusion of the aortic aneurysm.Procedure or surgery
Surgical procedure in which an aortic aneurysm is excluded.
| Study group | Role | What they receive |
|---|---|---|
| A | Group of patients in whom the left renal vein was divided for exposure of the aorta. Receives: Procedure: Exclusion of the aortic aneurysm. | |
| A+ | Subgroup of group A in whom a communicating vein to the left ascending lumbar vein was present. Receives: Procedure: Exclusion of the aortic aneurysm. | |
| A- | Subgroup of group A in whom a communicating vein to the left ascending lumbar vein was not present. Receives: Procedure: Exclusion of the aortic aneurysm. | |
| B | Group of patients in whom the left renal vein was mobilized but not divided for exposure of the aorta. Receives: Procedure: Exclusion of the aortic aneurysm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function after surgery.
The level of creatinine in the blood was measured after surgery at several time points.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Oct 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andreas Selberherr, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054972
- Sponsor's protocol ID
- ComLum
- Status last verified
- Sep 2021
- First submitted
- 19 Sep 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Renal Vein Division for Juxtarenal Aortic Exposure: Renal Function and Role of the Communicating Lumbar Vein
- ClinicalTrials.gov ID
- NCT05054972
- Acronym / sponsor ID
- ComLum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 23 Sep 2021 (actual)
- 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.
Retrospective study on the outcome of the renal function in patients operated because of juxtarenal aortic aneurysms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: Exclusion of the aortic aneurysm.Group of patients in whom the left renal vein was divided for exposure of the aorta. |
| A+ | – | Procedure: Exclusion of the aortic aneurysm.Subgroup of group A in whom a communicating vein to the left ascending lumbar vein was present. |
| A- | – | Procedure: Exclusion of the aortic aneurysm.Subgroup of group A in whom a communicating vein to the left ascending lumbar vein was not present. |
| B | – | Procedure: Exclusion of the aortic aneurysm.Group of patients in whom the left renal vein was mobilized but not divided for exposure of the aorta. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were treated surgically for a juxtrarenal aortic aneurysm with an open operation.
Key inclusion criteria (1 listed)
- Only patients who went for a planned operation because of a juxtarenal aortic aneurysm were included in this retrospective analysis.
Key exclusion criteria (1 listed)
- Emergency surgery Rupture Pending rupture
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 |
|---|---|---|
| Exclusion of the aortic aneurysm.Surgical procedure in which an aortic aneurysm is excluded. | Procedure or surgery | A, A+, A-, B |
Primary outcome
Renal function after surgery.
Time frame: 24 months
The level of creatinine in the blood was measured after surgery at several time points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Juxtarenal Aortic Aneurysm, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2021. 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 Austria. 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. 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?
Results are not available in the source record.
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?
Renal function after surgery. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2021.