Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test

Abdominal Compartment Syndrome Clinical Trial

— SCA-AAR  

Official title:

Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02859662
• Other study ID #: R/2015/49
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2016
• Last updated: November 6, 2017
• Start date: September 2016
• Est. completion date: March 2019

Study information

• Verified date: November 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Simon Rinckenbach, MD PhD
• Email: srinckenbach[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Compartment Syndrome
• Aneurysm
• Aortic Aneurysm
• Aortic Rupture
• Compartment Syndromes
• Intra-Abdominal Hypertension
• Rupture
• Syndrome

Intervention

Procedure:
• ruptured aortic aneurysm
All patients with ruptured abdominal aortic aneurysm may be included in this study, whatever the surgical treatment.

Locations

Country	Name	City	State
France	CHU	Bordeaux
France	CHU	Clermont-Ferrand
France	CH	Colmar
France	CHU	Dijon
France	CHU	Lyon
France	CH	Mulhouse
France	CHU	Nancy
France	CHU	Nantes
France	CHU	Rennes
France	CHU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a predictive score on the appearance of an abdominal compartment syndrome after a surgical treatment of a ruptured abdominal aortic aneurysm	score with criteria	30 days
Secondary	30 days mortality rate	Mortality	30 days
Secondary	the duration of hospitalisation (intensive care unit stay and total hospital stay)	Duration in day of hospitalisation	30 days