ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Socio-economic Vulnerability on Initial Severity and Prognosis in Patients Admitted to an ICU. (IVOIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01907581
Recruitment Status : Unknown
Verified July 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
A gravity admission largest resuscitation and a poorer prognosis are expected for patients experiencing socio-economic vulnerability. This is the first study in France and investigating the field of resuscitation which will allow us to have a vision of the French health system and its consequences. The frequency of PTSD is expected to be more important in this vulnerable population itself with quality of life at discharge worse. The results of this study are a prerequisite for the implementation of preventive measures targeted and more suitable for those patients experiencing socio-economic vulnerability remediation.

Condition or disease Intervention/treatment Phase
Patients at Intensive Care Unit Other: Quality of life questionnaires Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Socio-economic Vulnerability on Initial Severity and Prognosis in Patients Admitted to an ICU. Prospective, Multi-centre Cohort Study
Study Start Date : June 2013
Estimated Primary Completion Date : April 2015

Arm Intervention/treatment
Patients admitted to an ICU Other: Quality of life questionnaires



Primary Outcome Measures :
  1. Scale of activities of daily living [ Time Frame: baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who have been informed about the study (directly or via a person of trust) and have given their consent
  • Patients admitted to intensive care in accordance with the criteria defined by decree n° 2002-465 of the law of 05th April 2002 relative to the rights of patients and the quality of the healthcare system. It concerns patients who present or are likely to present life-threatening acute multi-organ failure requiring support care involving at least one of the following procedures: invasive or non-invasive mechanical ventilation, continuous or discontinuous hemofiltration, dobutamine, adrenaline, noradrenaline, ECMO

Exclusion Criteria:

  • - Refusal to take part,
  • Age < 18 years
  • Adult under guardianship (or ward of court),
  • Patients impossible to follow for 3 months (concomitant disease not related to the admission to the ICU that may cause death within 3 months….),
  • Patients presenting major cognitive impairment that precludes a reliable interview,
  • Patients and/or close relatives/friends who cannot be questioned or cannot provide information,
  • Absence of a family and/or close friends

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907581


Locations
France
CHU de Dijon Recruiting
Dijon, France, 21079
Contact: Maud CARPENTIER    03.80.29.35.10    maud.carpentier@chu-dijon.fr   
Principal Investigator: Jean-Pierre Quenot         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01907581     History of Changes
Other Study ID Numbers: Quenot PHRC IR 2012
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013