NCT03607019

Brief Summary

Socioeconomic inequalities are increasingly recognised as an important public health issue, and it is now well established that patients with socioeconomic deprivation (SED) features demonstrate higher mortality and morbidity. The epidemiology and impact of SED on the specific population of ICU patients has been insufficiently investigated. In this prospective multicenter study of patients admitted to 9 ICUs of the Paris area, the investigators aim to explore the epidemiology of SED features, and its impact on mortality and length of stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

May 31, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

July 13, 2018

Last Update Submit

May 25, 2022

Conditions

Socioeconomic Factors

Keywords

Intensive careCritical carePovertyinequalities

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    30-day mortality

    30 days

Secondary Outcomes (3)

  • ICU length of stay

    up to 12 weeks

  • Hospital length of stay

    up to 12 weeks

  • ICU mortality

    up to 12 weeks

Other Outcomes (2)

  • 30-day mortality of pre-specified subgroup of undocumented immigrants

    30 days

  • 30-day mortality of pre-specified subgroup of deprived patients aged between 18 and 25 years old

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All consecutive patients admitted to one of the participating ICUs during the study period

You may qualify if:

  • Age ≥ 18 years
  • Admission to one of the participating intensive care units

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centre Hospitalier Universitaire Ambroise Paré

Boulogne-Billancourt, 92104, France

Location

Centre Hospitalier Universitaire Louis Mourier

Colombes, 92701, France

Location

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, 91106, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Grand Hopital de l'Est Francilien

Jossigny, 77600, France

Location

Groupe Hospitalier Nord-Essone

Longjumeau, 91160, France

Location

Centre Hospitalier Intercommunal André Grégoire

Montreuil, 93100, France

Location

Centre Hospitalier Universitaire Lariboisière

Paris, 75010, France

Location

Centre Hospitalier de Saint-Denis

Saint-Denis, 93200, France

Location

Related Publications (6)

  • Marmot M, Allen J, Bell R, Bloomer E, Goldblatt P; Consortium for the European Review of Social Determinants of Health and the Health Divide. WHO European review of social determinants of health and the health divide. Lancet. 2012 Sep 15;380(9846):1011-29. doi: 10.1016/S0140-6736(12)61228-8. Epub 2012 Sep 8.

    PMID: 22964159BACKGROUND

  • Welch CA, Harrison DA, Hutchings A, Rowan K. The association between deprivation and hospital mortality for admissions to critical care units in England. J Crit Care. 2010 Sep;25(3):382-90. doi: 10.1016/j.jcrc.2009.11.003. Epub 2010 Jan 15.

    PMID: 20074907BACKGROUND

  • Zager S, Mendu ML, Chang D, Bazick HS, Braun AB, Gibbons FK, Christopher KB. Neighborhood poverty rate and mortality in patients receiving critical care in the academic medical center setting. Chest. 2011 Jun;139(6):1368-1379. doi: 10.1378/chest.10-2594. Epub 2011 Mar 31.

    PMID: 21454401BACKGROUND

  • Latour J, Lopez V, Rodriguez M, Nolasco A, Alvarez-Dardet C. Inequalities in health in intensive care patients. J Clin Epidemiol. 1991;44(9):889-94. doi: 10.1016/0895-4356(91)90051-a.

    PMID: 1890431BACKGROUND

  • Bein T, Hackner K, Zou T, Schultes S, Bosch T, Schlitt HJ, Graf BM, Olden M, Leitzmann M. Socioeconomic status, severity of disease and level of family members' care in adult surgical intensive care patients: the prospective ECSSTASI study. Intensive Care Med. 2012 Apr;38(4):612-9. doi: 10.1007/s00134-012-2463-x. Epub 2012 Jan 25.

    PMID: 22273749BACKGROUND

  • Bige N, Hejblum G, Baudel JL, Carron A, Chevalier S, Pichereau C, Maury E, Guidet B. Homeless Patients in the ICU: An Observational Propensity-Matched Cohort Study. Crit Care Med. 2015 Jun;43(6):1246-54. doi: 10.1097/CCM.0000000000000944.

    PMID: 25793435BACKGROUND

Study Officials

  • Etienne de Montmollin, MD

    Centre Hospitalier de Saint-Denis

    PRINCIPAL INVESTIGATOR

  • Morgan Benais, MD

    Centre Hospitalier de Saint-Denis

    STUDY CHAIR

  • Daniel Da Silva, MD

    Centre Hospitalier de Saint-Denis

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2018

First Posted

July 31, 2018

Study Start

March 5, 2018

Primary Completion

September 15, 2018

Study Completion

September 30, 2018

Last Updated

May 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)