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

• Conditions: Abdominal Compartment Syndrome

• Registration Number: NCT02859662
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Study Start: 2016-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-07
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a predictive score on the appearance of an abdominal compartment syndrome after a surgical treatment of a ruptured abdominal aortic aneurysm	30 days	score with criteria

Secondary Outcome Measures

Name	Time	Method
30 days mortality rate	30 days	Mortality
the duration of hospitalisation (intensive care unit stay and total hospital stay)	30 days	Duration in day of hospitalisation

Trial Locations

Locations (3)

CH; 🇫🇷 Mulhouse, France

CHU; 🇫🇷 Rennes, France

CHU Strasbourg; 🇫🇷 Strasbourg, France