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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02307136
Other study ID # NI11013-AOR11114
Secondary ID
Status Completed
Phase N/A
First received November 27, 2014
Last updated February 15, 2016
Start date January 2013
Est. completion date December 2015

Study information

Verified date February 2016
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50000
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Emergency Department, Bichat-Claude Bernard Hospital Paris Île-de-France

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Mortality in ICU and in other hospital units throughout the study: 5 years No
Primary Rate of direct transfer Rate of direct transfer from Emergency Unit to ICU throughout the study: 5 years No
Primary Rate of indirect transfer Rate of indirect transfer from a hospitalization Unit to ICU throughout the study: 5 years No
Primary Duration of stay in emergency department, in ICU and in hospital Duration of stay in emergency department, in ICU and in hospital throughout the study: 5 years No
Primary Mode of discharge from ICU Mode of discharge from ICU and direction of patient (home, other structures etc.) throughout the study: 5 years No
Secondary Severity scores Severity scores in ICU throughout the study: 5 years No
Secondary Use and duration of mechanical ventilation Use and duration of mechanical ventilation for patient during ICU stay throughout the study: 5 years No
Secondary Score of burden of care in ICU Score of burden of care in ICU throughout the study: 5 years No
Secondary Percentage of patients with ICU stay Percentage of patients with ICU stay throughout the study: 5 years No
Secondary Percentage of patients with continuing care Percentage of patients with continuing care after discharge from the ICU throughout the study: 5 years No
Secondary Frequency of dialysis Frequency of dialysis throughout the study: 5 years No
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