Abdominal Compartment SyndromeSCA-AARNCT02859662
Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test
An observational study of Abdominal Compartment Syndrome, run by Centre Hospitalier Universitaire de Besancon at 10 sites in France.
Trial summary
It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome. the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Compartment Syndrome
- What is being tested?
- ruptured aortic aneurysm
- Type of treatment
- Surgery or procedure
- How many people
- 165 participants
- Where
- 10 sitesFrance
- Study dates
- Sep 2016to Mar 2019
- 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: All patients with ruptured abdominal aortic aneurysm may be included in the study, whatever the surgical technique used.
Who may be able to join
- over 18
- to be hospitalized in participating hospitals
- ruptured aneurysm confirmed and operated
Who cannot join
- pregnancy
- patients with bladder tumor or bladder surgery or trauma bladder can distort bladder pressure measurement
- cystectomy
- patients died before arrival in the operating room
- patients died during surgery or within one hour of the initial surgical procedure
- patient whose abdominal closure at the end of the procedure is impossible
Trial locations and contacts
10 sites in 1 country.
Simon Rinckenbach, MD PhD contact
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CHU
Bordeaux
- Recruiting
CHU
Clermont-Ferrand
- Recruiting
CH
Colmar
- Recruiting
CHU
Dijon
Eric Steinmetz, MD, PhD
- Recruiting
CHU
Lyon
Patrick Lermusiaux, MD, PhD
- Recruiting
CH
Mulhouse
- Recruiting
CHU
Nancy
Nicla Settembre
- Recruiting
CHU
Nantes
- Recruiting
CHU
Rennes
- Recruiting
CHU Strasbourg
Strasbourg
About this study
It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome.
the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm
Read the detailed description
Despite improved management techniques of ruptured abdominal aortic aneurysm, especially in vascular surgery, the mortality rate has not decreased these last years.
The abdominal compartment syndrome (ACS) has been clearly identified as one of the main etiologies of mortality after ruptured aortic aneurysm. The mortality grow up with ACS in this population.
So, the investigators want to screen abdominal compartment syndrome in the operative room.
It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome.
the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm
Later the aim of a future study will be to screen ACS and manage patient as soon as possible to avoid it.
- Conditions
- Abdominal Compartment Syndrome
- Being tested
- ruptured aortic aneurysm
- Keywords
- abdominal compartment syndrome, abdominal aortic aneurysm, ruptured aneurysm
- Medical subject headings
- Intra-Abdominal Hypertension, Aortic Aneurysm, Abdominal, Aneurysm, Ruptured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ruptured aortic aneurysmProcedure or surgery
All patients with ruptured abdominal aortic aneurysm may be included in this study, whatever the surgical treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
a predictive score on the appearance of an abdominal compartment syndrome after a surgical treatment of a ruptured abdominal aortic aneurysm
score with criteria
Measured: 30 days
Secondary outcomes (2)
30 days mortality rate
Mortality
Measured: 30 days
the duration of hospitalisation (intensive care unit stay and total hospital stay)
Duration in day of hospitalisation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
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 Compartment SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Rinckenbach, MD PhD, Principal investigator, CHRU Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859662
- Sponsor's protocol ID
- R/2015/49
- Acronym
- SCA-AAR
- Status last verified
- Nov 2017
- First submitted
- 9 May 2016
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Leclerc B, Salomon Du Mont L, Parmentier AL, Besch G, Rinckenbach S. Abdominal compartment syndrome and ruptured aortic aneurysm: Validation of a predictive test (SCA-AAR). Medicine (Baltimore). 2018 Jun;97(25):e11066. doi: 10.1097/MD.0000000000011066.
PubMed 29923999
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test
- ClinicalTrials.gov ID
- NCT02859662
- Acronym / sponsor ID
- SCA-AAR / R/2015/49
- Conditions
- Abdominal Compartment Syndrome
- Keywords
- abdominal compartment syndrome, abdominal aortic aneurysm, ruptured aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 9 Aug 2016 (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.
It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome.
the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm
Detailed description
Despite improved management techniques of ruptured abdominal aortic aneurysm, especially in vascular surgery, the mortality rate has not decreased these last years.
The abdominal compartment syndrome (ACS) has been clearly identified as one of the main etiologies of mortality after ruptured aortic aneurysm. The mortality grow up with ACS in this population.
So, the investigators want to screen abdominal compartment syndrome in the operative room.
It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome.
the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm
Later the aim of a future study will be to screen ACS and manage patient as soon as possible to avoid it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with ruptured abdominal aortic aneurysm may be included in the study, whatever the surgical technique used.
Key inclusion criteria (3 listed)
- over 18
- to be hospitalized in participating hospitals
- ruptured aneurysm confirmed and operated
Key exclusion criteria (6 listed)
- pregnancy
- patients with bladder tumor or bladder surgery or trauma bladder can distort bladder pressure measurement
- cystectomy
- patients died before arrival in the operating room
- patients died during surgery or within one hour of the initial surgical procedure
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 |
|---|---|---|
| ruptured aortic aneurysmAll patients with ruptured abdominal aortic aneurysm may be included in this study, whatever the surgical treatment. | Procedure or surgery | – |
Primary outcome
a predictive score on the appearance of an abdominal compartment syndrome after a surgical treatment of a ruptured abdominal aortic aneurysm
Time frame: 30 days
score with criteria
2 secondary outcomes
30 days mortality rate
Time frame: 30 days
the duration of hospitalisation (intensive care unit stay and total hospital stay)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Derived from this study: PubMed 29923999Leclerc B, Salomon Du Mont L, Parmentier AL, Besch G, Rinckenbach S. Abdominal compartment syndrome and ruptured aortic aneurysm: Validation of a predictive test (SCA-AAR). Medicine (Baltimore). 2018 Jun;97(25):e11066. doi: 10.1097/MD.0000000000011066.
- 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.
Simon Rinckenbach, MD PhD contact
Simon Rinckenbach, MD PhD principal investigator
CHRU Besancon
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Compartment Syndrome, run by Centre Hospitalier Universitaire de Besancon at 10 sites in France.
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 3 inclusion and 6 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 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
Contact Simon Rinckenbach, MD PhD (srinckenbach@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a predictive score on the appearance of an abdominal compartment syndrome after a surgical treatment of a ruptured abdominal aortic aneurysm (time frame: 30 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 NCT02859662, 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 7 Nov 2017.