Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test (SCA-AAR)

November 6, 2017 updated by: Centre Hospitalier Universitaire de Besancon

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • CHU
      • Clermont-Ferrand, France
        • Recruiting
        • CHU
      • Colmar, France
        • Recruiting
        • CH
      • Dijon, France
        • Recruiting
        • CHU
        • Contact:
          • Eric Steinmetz, MD, PhD
      • Lyon, France
        • Recruiting
        • CHU
        • Contact:
          • Patrick Lermusiaux, MD, PhD
      • Mulhouse, France
        • Recruiting
        • CH
      • Nancy, France
        • Recruiting
        • CHU
        • Contact:
          • Nicla Settembre
      • Nantes, France
        • Recruiting
        • CHU
      • Rennes, France
        • Recruiting
        • CHU
      • Strasbourg, France
        • Recruiting
        • CHU Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 days mortality rate
Time Frame: 30 days
Mortality
30 days
the duration of hospitalisation (intensive care unit stay and total hospital stay)
Time Frame: 30 days
Duration in day of hospitalisation
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Simon Rinckenbach, MD PhD, CHRU Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

March 1, 2019

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (ESTIMATE)

August 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R/2015/49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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