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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03607019
Other study ID # 2017-A01272-51
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 5, 2018
Est. completion date September 30, 2018

Study information

Verified date March 2022
Source Centre Hospitalier de Saint-Denis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 234
Est. completion date September 30, 2018
Est. primary completion date September 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Admission to one of the participating intensive care units Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hospitalier Universitaire Ambroise Paré Boulogne-Billancourt
France Centre Hospitalier Universitaire Louis Mourier Colombes
France Centre Hospitalier Sud-Francilien Corbeil-Essonnes
France Centre Hospitalier Universitaire Henri Mondor Créteil
France Grand Hopital de l'Est Francilien Jossigny
France Groupe Hospitalier Nord-Essone Longjumeau
France Centre Hospitalier Intercommunal André Grégoire Montreuil
France Centre Hospitalier Universitaire Lariboisière Paris
France Centre Hospitalier de Saint-Denis Saint-Denis

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier de Saint-Denis

Country where clinical trial is conducted

France, 

References & Publications (6)

Bein T, Hackner K, Zou T, Schultes S, Bösch 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. — View Citation

Bigé 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. — View Citation

Latour J, López V, Rodriguez M, Nolasco A, Alvarez-Dardet C. Inequalities in health in intensive care patients. J Clin Epidemiol. 1991;44(9):889-94. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 30-day mortality of pre-specified subgroup of undocumented immigrants 30-day mortality of pre-specified subgroup of patients who are undocumented 30 days
Other 30-day mortality of pre-specified subgroup of deprived patients aged between 18 and 25 years old 30-day mortality of pre-specified subgroup of deprived patients (ie without healthcare coverage and/or without income and/or without housing) aged between 18 and 25 years old 30 days
Primary 30-day mortality 30-day mortality 30 days
Secondary ICU length of stay ICU length of stay up to 12 weeks
Secondary Hospital length of stay Hospital length of stay up to 12 weeks
Secondary ICU mortality ICU mortality up to 12 weeks
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