Clinical trial NCT02859662: Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test
Official title: Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Compartment Syndrome
Keywords: abdominal compartment syndrome
abdominal aortic aneurysm
ruptured aneurysm
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with ruptured abdominal aortic aneurysm may be included in the study, whatever the surgical technique used.

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* over 18
* to be hospitalized in participating hospitals
* ruptured aneurysm confirmed and operated

Exclusion Criteria:

* 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

Primary outcomes:
measure: a predictive score on the appearance of an abdominal compartment syndrome after a surgical treatment of a ruptured abdominal aortic aneurysm
timeFrame: 30 days
Secondary outcomes:
measure: 30 days mortality rate
timeFrame: 30 days
measure: the duration of hospitalisation (intensive care unit stay and total hospital stay)
timeFrame: 30 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU
city: Clermont-Ferrand
country: France
facility: CHU
city: Colmar
country: France
facility: CH
city: Dijon
country: France
facility: CHU
city: Lyon
country: France
facility: CHU
city: Mulhouse
country: France
facility: CH
city: Nancy
country: France
facility: CHU
city: Nantes
country: France
facility: CHU
city: Rennes
country: France
facility: CHU
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
affiliation: CHRU Besancon
name: Simon Rinckenbach, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.