Evaluation of the Impact of Within-hospital Trajectories of Patients Admitted in Intensive Care Units (ICU) From Emergency Departments (SUREA)

February 15, 2016 updated by: Assistance Publique - Hôpitaux de Paris

This multicenter cohort aims to assess the impact of within-hospital trajectories of patients admitted in intensive care units from emergency departments on vital prognosis of patients, duration of hospital stay and hospital costs.

As secondary objectives, the study will:

  • assess the impact of clinical and demographic characteristics on hospital trajectories of patients.
  • assess the impact of emergency units workload, beds availability in medical units and in intensive care units, and global hospital organisation on patients care trajectories.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The study will be performed in emergency departments and ICUs of university hospitals. 15 emergency departments and 36 ICUs of APHP (the public hospital system of the city of Paris) will be involved.

The study will assemble the data from 50,000 to 80,000 patients in total.

Eligible patients are admitted in ICUs between 01/01/2007 and 12/31/2011.

Extraction of the patients' data will be performed with processing software utilised in APHP, i.e. Healthcare Information System Program (PMSI, Urqual, Gilda...etc.).

Collected patients' data span the period from admission in emergency department or medical department unitl hospital discharge.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50000

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
    • Île-de-France
      • Paris, Île-de-France, France, 75018
        • Emergency Department, Bichat-Claude Bernard Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population under study is formed of patients admitted in 3 types of intensive care units (Medical intensive care unit, Surgical Intensive Care Unit and Cardiac Intensive Care Unit), transferred from emergency departments, either directly, or from another Department such as a Unit of short durations of hospitalization.

Description

Inclusion Criteria:

  • Adult patient directly admitted in ICU from emergency departments of APHP (the public hospital system of the city of Paris).
  • Adult patient indirectly transferred to ICU from an hospitalization unit, initially admitted from an emergency department of APHP.

Exclusion Criteria:

  • Patient transferred from APHP toward an external hospital, outside APHP, before being admitted in an ICU.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: throughout the study: 5 years
Mortality in ICU and in other hospital units
throughout the study: 5 years
Rate of direct transfer
Time Frame: throughout the study: 5 years
Rate of direct transfer from Emergency Unit to ICU
throughout the study: 5 years
Rate of indirect transfer
Time Frame: throughout the study: 5 years
Rate of indirect transfer from a hospitalization Unit to ICU
throughout the study: 5 years
Duration of stay in emergency department, in ICU and in hospital
Time Frame: throughout the study: 5 years
Duration of stay in emergency department, in ICU and in hospital
throughout the study: 5 years
Mode of discharge from ICU
Time Frame: throughout the study: 5 years
Mode of discharge from ICU and direction of patient (home, other structures etc.)
throughout the study: 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity scores
Time Frame: throughout the study: 5 years
Severity scores in ICU
throughout the study: 5 years
Use and duration of mechanical ventilation
Time Frame: throughout the study: 5 years
Use and duration of mechanical ventilation for patient during ICU stay
throughout the study: 5 years
Score of burden of care in ICU
Time Frame: throughout the study: 5 years
Score of burden of care in ICU
throughout the study: 5 years
Percentage of patients with ICU stay
Time Frame: throughout the study: 5 years
Percentage of patients with ICU stay
throughout the study: 5 years
Percentage of patients with continuing care
Time Frame: throughout the study: 5 years
Percentage of patients with continuing care after discharge from the ICU
throughout the study: 5 years
Frequency of dialysis
Time Frame: throughout the study: 5 years
Frequency of dialysis
throughout the study: 5 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Enrique CASALINO, MD, PhD, APHP

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NI11013-AOR11114

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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