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

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

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 Overview

• Status: Completed
• Conditions: Patients at Intensive Care Unit
• Intervention / Treatment: Other: Quality of life questionnaires

• Study Type: Interventional
• Enrollment (Actual): 1417
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU de Dijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients admitted to an ICU	Other: Quality of life questionnaires

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Publications and helpful links

General Publications

• Quenot JP, Helms J, Labro G, Dargent A, Meunier-Beillard N, Ksiazek E, Bollaert PE, Louis G, Large A, Andreu P, Bein C, Rigaud JP, Perez P, Clere-Jehl R, Merdji H, Devilliers H, Binquet C, Meziani F, Fournel I; IVOIRE Trial Investigators and the CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). Influence of deprivation on initial severity and prognosis of patients admitted to the ICU: the prospective, multicentre, observational IVOIRE cohort study. Ann Intensive Care. 2020 Feb 11;10(1):20. doi: 10.1186/s13613-020-0637-1.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2013
• Primary Completion (Actual): September 26, 2017
• Study Completion (Actual): October 25, 2017

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Quenot PHRC IR 2012