Intensive Care UnitsSUREANCT02307136
Evaluation of the Impact of Within-hospital Trajectories of Patients Admitted in Intensive Care Units (ICU) From Emergency Departments
An observational study of Intensive Care Units and Emergency Department, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Units, Emergency Department
- How many people
- 50,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient transferred from APHP toward an external hospital, outside APHP, before being admitted in an ICU.
Trial locations and contacts
1 site in 1 country.
France1 site
Emergency Department, Bichat-Claude Bernard Hospital
Paris, Île-de-France Region, 75018
About this study
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.
Read the 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.
- Conditions
- Intensive Care Units, Emergency Department
- Keywords
- intensive care units, emergency department
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality in ICU and in other hospital units
Measured: throughout the study: 5 years
Rate of direct transfer
Rate of direct transfer from Emergency Unit to ICU
Measured: throughout the study: 5 years
Rate of indirect transfer
Rate of indirect transfer from a hospitalization Unit to ICU
Measured: 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
Measured: throughout the study: 5 years
Mode of discharge from ICU
Mode of discharge from ICU and direction of patient (home, other structures etc.)
Measured: throughout the study: 5 years
Secondary outcomes (6)
Severity scores
Severity scores in ICU
Measured: throughout the study: 5 years
Use and duration of mechanical ventilation
Use and duration of mechanical ventilation for patient during ICU stay
Measured: throughout the study: 5 years
Score of burden of care in ICU
Score of burden of care in ICU
Measured: throughout the study: 5 years
Percentage of patients with ICU stay
Percentage of patients with ICU stay
Measured: throughout the study: 5 years
Percentage of patients with continuing care
Percentage of patients with continuing care after discharge from the ICU
Measured: throughout the study: 5 years
Frequency of dialysis
Frequency of dialysis
Measured: throughout the study: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique CASALINO, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307136
- Sponsor's protocol ID
- NI11013-AOR11114
- Acronym
- SUREA
- Status last verified
- Feb 2016
- First submitted
- 27 Nov 2014
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Within-hospital Trajectories of Patients Admitted in Intensive Care Units (ICU) From Emergency Departments
- ClinicalTrials.gov ID
- NCT02307136
- Acronym / sponsor ID
- SUREA / NI11013-AOR11114
- Conditions
- Intensive Care Units, Emergency Department
- Keywords
- intensive care units, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient transferred from APHP toward an external hospital, outside APHP, before being admitted in an ICU.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: throughout the study: 5 years
Mortality in ICU and in other hospital units
Rate of direct transfer
Time frame: throughout the study: 5 years
Rate of direct transfer from Emergency Unit to ICU
Rate of indirect transfer
Time frame: throughout the study: 5 years
Rate of indirect transfer from a hospitalization Unit to ICU
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
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.)
6 secondary outcomes
Severity scores
Time frame: throughout the study: 5 years
Use and duration of mechanical ventilation
Time frame: throughout the study: 5 years
Score of burden of care in ICU
Time frame: throughout the study: 5 years
Percentage of patients with ICU stay
Time frame: throughout the study: 5 years
Percentage of patients with continuing care
Time frame: throughout the study: 5 years
Frequency of dialysis
Time frame: throughout the study: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique CASALINO, MD, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Units and Emergency Department, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: throughout the study: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.