Completed

NCT Number: NCT01907581

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

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.

Completed

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Key information

Conditions

Patients at Intensive Care Unit

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Dijon

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life questionnaires

Other

Primary outcomes

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

Time frame: Within the first 24 hours of hospitalization in intensive care
Rate of mortality within 3 months following ICU admission

Time frame: within 3 months following ICU admission

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: IVOIRE

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Jul 25, 2013
Registry last updated: Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.