Patients at Intensive Care UnitIVOIRENCT01907581
Impact of Socio-economic Vulnerability on Initial Severity and Prognosis in Patients Admitted to an ICU.
A study testing Quality of life questionnaires in people with Patients at Intensive Care Unit, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients at Intensive Care Unit
- What is being tested?
- Quality of life questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,417 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2013to 25 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Patients at Intensive Care Unit
- Being tested
- Quality of life questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to an ICU | Other | Not described Receives: Other: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity at admission assessed by the SAPS II score at ICU admission
Measured: Within the first 24 hours of hospitalization in intensive care
Rate of mortality within 3 months following ICU admission
Measured: within 3 months following ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study start8 Jun 2013
- Primary completion26 Sep 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients at Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907581
- Sponsor's protocol ID
- Quenot PHRC IR 2012
- Acronym
- IVOIRE
- Status last verified
- Feb 2026
- First submitted
- 17 Jul 2013
- Last updated
- 9 Feb 2026
- Results posted
- No
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.
PubMed 32048075
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Socio-economic Vulnerability on Initial Severity and Prognosis in Patients Admitted to an ICU. Prospective, Multi-centre Cohort Study
- ClinicalTrials.gov ID
- NCT01907581
- Acronym / sponsor ID
- IVOIRE / Quenot PHRC IR 2012
- Conditions
- Patients at Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,417 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 8 Jun 2013 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to an ICU | Other | Other: Quality of life questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- - 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnaires | Other | Patients admitted to an ICU |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 32048075Quenot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life questionnaires in people with Patients at Intensive Care Unit, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity at admission assessed by the SAPS II score at ICU admission (time frame: Within the first 24 hours of hospitalization in intensive care). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01907581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.