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Clinical Trials/NCT01907581
NCT01907581CompletedNot Applicable

Impact of Socio-economic Vulnerability on Initial Severity and Prognosis in Patients Admitted to an ICU. Prospective, Multi-centre Cohort Study

Centre Hospitalier Universitaire Dijon1 site in 1 country1,417 target enrollmentStarted: June 8, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,417
Locations
1
Primary Endpoint
Rate of mortality within 3 months following ICU admission

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Patients admitted to an ICU

Other

Intervention: Quality of life questionnaires (Other)

Outcomes

Primary Outcomes

Rate of mortality within 3 months following ICU admission

Time Frame: within 3 months following ICU admission

Severity at admission assessed by the SAPS II score at ICU admission

Time Frame: Within the first 24 hours of hospitalization in intensive care

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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