NCT02307136

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

2.9 years

First QC Date

November 27, 2014

Last Update Submit

February 15, 2016

Conditions

Keywords

intensive care unitsemergency department

Outcome Measures

Primary Outcomes (5)

  • Mortality

    Mortality in ICU and in other hospital units

    throughout the study: 5 years

  • Rate of direct transfer

    Rate of direct transfer from Emergency Unit to ICU

    throughout the study: 5 years

  • Rate of indirect transfer

    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

    Duration of stay in emergency department, in ICU and in hospital

    throughout the study: 5 years

  • Mode of discharge from ICU

    Mode of discharge from ICU and direction of patient (home, other structures etc.)

    throughout the study: 5 years

Secondary Outcomes (6)

  • Severity scores

    throughout the study: 5 years

  • Use and duration of mechanical ventilation

    throughout the study: 5 years

  • Score of burden of care in ICU

    throughout the study: 5 years

  • Percentage of patients with ICU stay

    throughout the study: 5 years

  • Percentage of patients with continuing care

    throughout the study: 5 years

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department, Bichat-Claude Bernard Hospital

Paris, Île-de-France Region, 75018, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Enrique CASALINO, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 4, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations