Aortic Aneurysm, AbdominalNCT01704391
Haemodynamic Response to Aortic Surgery
An observational study of Aortic Aneurysm, Abdominal and Aortic Diseases, run by Sygehus Lillebaelt at 1 site in Denmark.
Trial summary
Open elective abdominal aortic surgery is a high risk procedure involving clamping of the aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD) causing lower limb ischaemia. These patients are often regarded as one entity in postoperative study settings. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Aortic Diseases, Acute Kidney Injury
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to May 2015
- 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: 10 patients sceduled for elective open operation for aortic aneurysm disease and 10 patients sceduled for elective open operation for aortic occlusive disease
Who may be able to join
- CT verified aortic aneurysm or aortic occlusive disease
Who cannot join
- age<18 y
- contraindications to the use of oesophagus doppler monitor, eg mycosis, perforation, stenosis.
Trial locations and contacts
1 site in 1 country.
About this study
Open elective abdominal aortic surgery is a high risk procedure involving clamping of the aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD) causing lower limb ischaemia.
These patients are often regarded as one entity in postoperative study settings. However, previous studies indicate that risk profiles, inflammatory activity, and haemodynamic capacity may differ between these groups. The first aim of this study was to evaluate postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute dialysis than did patients with AOD.
Read more
The investigators see a relatively high incidence of postoperative acute kidney injury (AKI) following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory response to aortic cross clamping may per se induce a rise in NGAL despite intact renal function. Therefore NGAL may not be a reliable marker of AKI after AAS.
The second aim of this study is to describe the changes in NGAL after AAS in patients with and without postoperative dialysis-dependent AKI.
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aortic Diseases, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aortic aneurysm patients | 10 patients with a CT verified diagnosis of aortic aneurysm demanding open elective surgical correction with insertion of vascular prosthesis | |
| Aortic occlusive disease patients | 10 patients with CT verified aortic occlusive disease demanding open elective surgical correction with insertion of vascular prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU length of stay
Number of patients with an ICU LOS > 24 hours
Measured: 24 hours postoperatively
Post-operative need for dialysis
Number of patients developing dialysis dependency during the first 72 hours postoperatively
Measured: 72 hours postoperatively
Secondary outcomes (1)
Hemodynamic peroperative changes in AAD vs AOD
Stroke volume, cardiac index, systemic vasular resistance is recorded for AAD- and AOD patients at five time points during the operation using CardioQ, an oesophagus doppler monitor.
Measured: After anaesthesia induction, 10 minutes after aortic cross-clamping, 10 minutes after reperfusion, end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Korvenius Nedergaard, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704391
- Sponsor's protocol ID
- S-20110154
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2012
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic Response to Aortic Surgery
- ClinicalTrials.gov ID
- NCT01704391
- Acronym / sponsor ID
- S-20110154
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Oct 2012 (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.
Open elective abdominal aortic surgery is a high risk procedure involving clamping of the aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD) causing lower limb ischaemia.
These patients are often regarded as one entity in postoperative study settings. However, previous studies indicate that risk profiles, inflammatory activity, and haemodynamic capacity may differ between these groups. The first aim of this study was to evaluate postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute dialysis than did patients with AOD.
The investigators see a relatively high incidence of postoperative acute kidney injury (AKI) following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory response to aortic cross clamping may per se induce a rise in NGAL despite intact renal function. Therefore NGAL may not be a reliable marker of AKI after AAS.
The second aim of this study is to describe the changes in NGAL after AAS in patients with and without postoperative dialysis-dependent AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aortic aneurysm patients | – | –10 patients with a CT verified diagnosis of aortic aneurysm demanding open elective surgical correction with insertion of vascular prosthesis |
| Aortic occlusive disease patients | – | –10 patients with CT verified aortic occlusive disease demanding open elective surgical correction with insertion of vascular prosthesis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients sceduled for elective open operation for aortic aneurysm disease and 10 patients sceduled for elective open operation for aortic occlusive disease
Key inclusion criteria (1 listed)
- CT verified aortic aneurysm or aortic occlusive disease
Key exclusion criteria (2 listed)
- age<18 y
- contraindications to the use of oesophagus doppler monitor, eg mycosis, perforation, stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU length of stay
Time frame: 24 hours postoperatively
Number of patients with an ICU LOS > 24 hours
Post-operative need for dialysis
Time frame: 72 hours postoperatively
Number of patients developing dialysis dependency during the first 72 hours postoperatively
1 secondary outcome
Hemodynamic peroperative changes in AAD vs AOD
Time frame: After anaesthesia induction, 10 minutes after aortic cross-clamping, 10 minutes after reperfusion, end of surgery
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 18 Oct 2021.
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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, Abdominal and Aortic Diseases, run by Sygehus Lillebaelt 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 1 inclusion and 2 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 18 Oct 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 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. 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?
ICU length of stay (time frame: 24 hours postoperatively). The study lists 2 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 18 Oct 2021.