Social Deprivation Features in Intensive Care Unit Patients (PRECAREA)

May 25, 2022 updated by: Centre Hospitalier de Saint-Denis

Epidemiology and Prognostic Impact of Social Deprivation Features in Intensive Care Unit Patients

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-Billancourt, France, 92104
        • Centre Hospitalier Universitaire Ambroise Pare
      • Colombes, France, 92701
        • Centre Hospitalier Universitaire Louis Mourier
      • Corbeil-Essonnes, France, 91106
        • Centre Hospitalier Sud-Francilien
      • Créteil, France, 94010
        • Centre Hospitalier Universitaire Henri Mondor
      • Jossigny, France, 77600
        • Grand Hôpital de l'Est Francilien
      • Longjumeau, France, 91160
        • Groupe Hospitalier Nord-Essone
      • Montreuil, France, 93100
        • Centre hospitalier Intercommunal André Grégoire
      • Paris, France, 75010
        • Centre Hospitalier Universitaire Lariboisiere
      • Saint-Denis, France, 93200
        • Centre Hospitalier de Saint-Denis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: 30 days
30-day mortality
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: up to 12 weeks
ICU length of stay
up to 12 weeks
Hospital length of stay
Time Frame: up to 12 weeks
Hospital length of stay
up to 12 weeks
ICU mortality
Time Frame: up to 12 weeks
ICU mortality
up to 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality of pre-specified subgroup of undocumented immigrants
Time Frame: 30 days
30-day mortality of pre-specified subgroup of patients who are undocumented
30 days
30-day mortality of pre-specified subgroup of deprived patients aged between 18 and 25 years old
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Saint-Denis

Investigators

  • Principal Investigator: Etienne de Montmollin, MD, Centre Hospitalier de Saint-Denis
  • Study Chair: Morgan Benais, MD, Centre Hospitalier de Saint-Denis
  • Study Chair: Daniel Da Silva, MD, Centre Hospitalier de Saint-Denis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 5, 2018

Primary Completion (ACTUAL)

September 15, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (ACTUAL)

July 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-A01272-51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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