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

NCT ID: NCT02859662

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-03-31

Brief Summary

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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

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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

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Abdominal Compartment Syndrome

Keywords

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abdominal compartment syndrome abdominal aortic aneurysm ruptured aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ruptured aortic aneurysm

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Rinckenbach, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Besancon

Locations

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CHU

Bordeaux, , France

Site Status RECRUITING

CHU

Clermont-Ferrand, , France

Site Status RECRUITING

CH

Colmar, , France

Site Status RECRUITING

CHU

Dijon, , France

Site Status RECRUITING

CHU

Lyon, , France

Site Status RECRUITING

CH

Mulhouse, , France

Site Status RECRUITING

CHU

Nancy, , France

Site Status RECRUITING

CHU

Nantes, , France

Site Status RECRUITING

CHU

Rennes, , France

Site Status RECRUITING

CHU Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Simon Rinckenbach, MD PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Eric Steinmetz, MD, PhD

Role: primary

Patrick Lermusiaux, MD, PhD

Role: primary

Nicla Settembre

Role: primary

References

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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.

Reference Type DERIVED
PMID: 29923999 (View on PubMed)

Other Identifiers

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R/2015/49

Identifier Type: -

Identifier Source: org_study_id