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

Not Applicable

Completed

• Conditions: Patients at Intensive Care Unit
• Interventions: Other: Quality of life questionnaires

• Registration Number: NCT01907581
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-08
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-25
• Primary Completion: 2017-09-26
• Study Completion: 2017-10-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1417

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients admitted to an ICU	Quality of life questionnaires	-

Primary Outcome Measures

Name	Time	Method
Rate of mortality within 3 months following ICU admission	within 3 months following ICU admission
Severity at admission assessed by the SAPS II score at ICU admission	Within the first 24 hours of hospitalization in intensive care

Trial Locations

Locations (1)

CHU de Dijon; 🇫🇷 Dijon, France