Postoperative ComplicationsNCT05647486
Predictors of 30-day Postoperative Outcome After Elective EVAR
An observational study of Postoperative Complications, run by University of Thessaly at 1 site in Greece.
Trial summary
This study investigated the 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- 30-day postoperative outcome
- How many people
- 322 participants
- Where
- 1 siteGreece
- Study dates
- 23 Mar 2016to 13 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included consecutive AAA patients treated electively by EVAR
Who may be able to join
- Only patients managed with EVAR using standard bifurcated devices in elective setting were included.
Who cannot join
- Patients treated for ruptured, symptomatic, inflammatory or infectious AAA were excluded. Furthermore, any patient needing complex endovascular repair of the proximal landing zone was considered ineligible. Additional exclusion criteria were the presence of any trauma or surgery within two months before EVAR, any autoimmune or systemic inflammatory disease and any malignancy. Of note, any patient with clinical or laboratory signs of infection before the scheduled operation was not offered an EVAR until a complete resolution of the infection was confirmed via a clinical, laboratory and/or imaging evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of 30-day Postoperative Outcome After Elective Endovascular Abdominal Aortic Aneurysm Repair
This study investigated the 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics
Read the detailed description
The study included 322 consecutive AAA patients treated electively with EVAR from March 2016 to February 2019 at a tertiary referral center.
Early follow-up with clinical and laboratory evaluation took place at the 30rd day post-operatively. Any adverse event, such as major adverse cardiovascular events (MACE), post-implantation syndrome (PIS), acute kidney injury (AKI), and deaths of any cause were recorded.
- Conditions
- Postoperative Complications
- Being tested
- 30-day postoperative outcome
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30-day postoperative outcomeOther
The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed
| Study group | Role | What they receive |
|---|---|---|
| EVAR | Patients with AAA, treated electively by EVAR. The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed. Receives: Other: 30-day postoperative outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with major adverse cardiovascular events
Number of participants with major adverse cardiovascular events
Measured: 30rd day post-operatively
Number of patients with acute kidney injury
Number of participants with acute kidney injury according to the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) criteria
Measured: 30rd day post-operatively
Number of patients with post-implantation syndrome
Number of participants with post-implantation syndrome SIRS, without any apparent sign of infection
Measured: 30rd day post-operatively
Deaths of any cause
Number of participants who died from any cause
Measured: 30rd day post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start23 Mar 2016
- Primary completion1 Dec 2020
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutoglou, Professor, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647486
- Sponsor's protocol ID
- 30-day outcome, EVAR
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of 30-day Postoperative Outcome After Elective Endovascular Abdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT05647486
- Acronym / sponsor ID
- 30-day outcome, EVAR
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 12 Dec 2022 (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.
This study investigated the 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics
Detailed description
The study included 322 consecutive AAA patients treated electively with EVAR from March 2016 to February 2019 at a tertiary referral center.
Early follow-up with clinical and laboratory evaluation took place at the 30rd day post-operatively. Any adverse event, such as major adverse cardiovascular events (MACE), post-implantation syndrome (PIS), acute kidney injury (AKI), and deaths of any cause were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVAR | – | Other: 30-day postoperative outcomePatients with AAA, treated electively by EVAR. The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included consecutive AAA patients treated electively by EVAR
Key inclusion criteria (1 listed)
- Only patients managed with EVAR using standard bifurcated devices in elective setting were included.
Key exclusion criteria (1 listed)
- Patients treated for ruptured, symptomatic, inflammatory or infectious AAA were excluded. Furthermore, any patient needing complex endovascular repair of the proximal landing zone was considered ineligible. Additional exclusion criteria were the presence of any trauma or surgery within two months before EVAR, any autoimmune or systemic inflammatory disease and any malignancy. Of note, any patient with clinical or laboratory signs of infection before the scheduled operation was not offered an EVAR until a complete resolution of the infection was confirmed via a clinical, laboratory and/or imaging evaluation.
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 |
|---|---|---|
| 30-day postoperative outcomeThe 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed | Other | EVAR |
Primary outcome
Number of patients with major adverse cardiovascular events
Time frame: 30rd day post-operatively
Number of participants with major adverse cardiovascular events
Number of patients with acute kidney injury
Time frame: 30rd day post-operatively
Number of participants with acute kidney injury according to the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) criteria
Number of patients with post-implantation syndrome
Time frame: 30rd day post-operatively
Number of participants with post-implantation syndrome SIRS, without any apparent sign of infection
Deaths of any cause
Time frame: 30rd day post-operatively
Number of participants who died from any cause
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 12 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Eleni Arnaoutoglou, Professor study chair
University of Thessaly
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 Postoperative Complications, run by University of Thessaly at 1 site in Greece.
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: finished, as of the sponsor's last update on 12 Dec 2022. 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 Greece. 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?
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?
Number of patients with major adverse cardiovascular events (time frame: 30rd day post-operatively). The study lists 4 primary outcomes in all. 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 12 Dec 2022.