Critical IllnessICU_ACTIVITYNCT05353023
Intensive Care Unit Activity in France From the National Database Between 2013 and 2019
An observational study of Critical Illness and Intensive Care Unit, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Using data from the French National Uniform Hospital Discharge Database (systematically collecting administrative and medical information related to all hospitalized patients in France for care reimbursement purposes), the present study retrospectively assesses the activity of the French Intensive Care Unit… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Intensive Care Unit
- How many people
- 1,594,801 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2013to 31 Dec 2023
- 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: All adults patients admitted in French ICU between January 1st, 2013, to December 31st, 2019
Who may be able to join
- All adults patients admitted in French ICU between January 1st, 2013, to December 31st, 2019
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Care Unit Activity in France From the National Database Between 2013 and 2019: More Critically Ill Patients, Shorter Stay and Lower Mortality Rate
Using data from the French National Uniform Hospital Discharge Database (systematically collecting administrative and medical information related to all hospitalized patients in France for care reimbursement purposes), the present study retrospectively assesses the activity of the French Intensive Care Unit (ICU)(1,594,801 ICU admissions):
- In-ICU and in-hospital mortality rates
- Length of stay in ICU and hospital
- Mortality-associated factors during the study period.
- Number of organ failures
- Bed occupancy,
- Regional variations in previous indicators
- Conditions
- Critical Illness, Intensive Care Unit
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU ADMISSION | All patients admitted in a French intensive care unit over a 7-year period (2013 to 2019) using the French National Uniform Hospital Discharge Database (PMSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution in mortality rate
evolution of the mortality rate of ICU patients over the study period (2013-19)
Measured: from January 1st, 2013, to December 31st, 2019
Evolution in organ failure rate
evolution of the organ failure rate of ICU patients over the study period (2013-19)
Measured: from January 1st, 2013, to December 31st, 2019
Evolution in ICU stay
evolution of the ICU stay of ICU patients over the study period (2013-19)
Measured: from January 1st, 2013, to December 31st, 2019
Evolution in SAPS (Simplified Acute Physiology Score) II score at admission
evolution of the SAPS II score at admission of ICU patients over the study period (2013-19)
Measured: from January 1st, 2013, to December 31st, 2019
Evolution in age at admission
evolution of the age at admission of ICU patients over the study period (2013-19)
Measured: from January 1st, 2013, to December 31st, 2019
Evolution in sex ratio
evolution of the sex ratio of ICU patients over the study period (2013-19)
Measured: from January 1st, 2013, to December 31st, 2019
Secondary outcomes (4)
Proportion of patients admitted in ICU with at least 2 different organ failures
evolution of the proportion of patients admitted in ICU with at least 2 different organ failures corresponding to the definition of ICU in France.
Measured: from January 1st, 2013, to December 31st, 2019
- Proportion of patients admitted in ICU with a SAPS II score over 15 and with a specific ICU supportive therapy
Evolution of the proportion of patients admitted in ICU with a SAPS II score over 15 and with a specific ICU supportive therapy leading to a reimbursement by the French national health insurance.
Measured: from January 1st, 2013, to December 31st, 2019
Factors Associated with in-ICU mortality
Effect of year-time on in-ICU mortality
Measured: from January 1st, 2013, to December 31st, 2019
Regional variations
Evolution and potential differences between French regions in admission level
Measured: from January 1st, 2013, to December 31st, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Jan 2013
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 1,594,801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Yves LEFRANT, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353023
- Sponsor's protocol ID
- LOCAL/2022/JYL-01
- Acronym
- ICU_ACTIVITY
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boulet N, Boussere A, Mezzarobba M, Sofonea MT, Payen D, Lipman J, Laupland KB, Rello J, Lefrant JY, Muller L, Roger C, Pirracchio R, Mura T, Boudemaghe T. Intensive Care Unit activity in France from the national database between 2013 and 2019: More critically ill patients, shorter stay and lower mortality rate. Anaesth Crit Care Pain Med. 2023 Oct;42(5):101228. doi: 10.1016/j.accpm.2023.101228. Epub 2023 Apr 7.
PubMed 37031815
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Unit Activity in France From the National Database Between 2013 and 2019: More Critically Ill Patients, Shorter Stay and Lower Mortality Rate
- ClinicalTrials.gov ID
- NCT05353023
- Acronym / sponsor ID
- ICU_ACTIVITY / LOCAL/2022/JYL-01
- Conditions
- Critical Illness, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,594,801 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- 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.
Using data from the French National Uniform Hospital Discharge Database (systematically collecting administrative and medical information related to all hospitalized patients in France for care reimbursement purposes), the present study retrospectively assesses the activity of the French Intensive Care Unit (ICU)(1,594,801 ICU admissions):
- In-ICU and in-hospital mortality rates
- Length of stay in ICU and hospital
- Mortality-associated factors during the study period.
- Number of organ failures
- Bed occupancy,
- Regional variations in previous indicators
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU ADMISSION | – | –All patients admitted in a French intensive care unit over a 7-year period (2013 to 2019) using the French National Uniform Hospital Discharge Database (PMSI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults patients admitted in French ICU between January 1st, 2013, to December 31st, 2019
Key inclusion criteria (1 listed)
- All adults patients admitted in French ICU between January 1st, 2013, to December 31st, 2019
Key exclusion criteria (0 listed)
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
Evolution in mortality rate
Time frame: from January 1st, 2013, to December 31st, 2019
evolution of the mortality rate of ICU patients over the study period (2013-19)
Evolution in organ failure rate
Time frame: from January 1st, 2013, to December 31st, 2019
evolution of the organ failure rate of ICU patients over the study period (2013-19)
Evolution in ICU stay
Time frame: from January 1st, 2013, to December 31st, 2019
evolution of the ICU stay of ICU patients over the study period (2013-19)
Evolution in SAPS (Simplified Acute Physiology Score) II score at admission
Time frame: from January 1st, 2013, to December 31st, 2019
evolution of the SAPS II score at admission of ICU patients over the study period (2013-19)
Evolution in age at admission
Time frame: from January 1st, 2013, to December 31st, 2019
evolution of the age at admission of ICU patients over the study period (2013-19)
Evolution in sex ratio
Time frame: from January 1st, 2013, to December 31st, 2019
evolution of the sex ratio of ICU patients over the study period (2013-19)
4 secondary outcomes
Proportion of patients admitted in ICU with at least 2 different organ failures
Time frame: from January 1st, 2013, to December 31st, 2019
- Proportion of patients admitted in ICU with a SAPS II score over 15 and with a specific ICU supportive therapy
Time frame: from January 1st, 2013, to December 31st, 2019
Factors Associated with in-ICU mortality
Time frame: from January 1st, 2013, to December 31st, 2019
Regional variations
Time frame: from January 1st, 2013, to December 31st, 2019
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 4 Dec 2025.
- Results publication: PubMed 37031815Boulet N, Boussere A, Mezzarobba M, Sofonea MT, Payen D, Lipman J, Laupland KB, Rello J, Lefrant JY, Muller L, Roger C, Pirracchio R, Mura T, Boudemaghe T. Intensive Care Unit activity in France from the national database between 2013 and 2019: More critically ill patients, shorter stay and lower mortality rate. Anaesth Crit Care Pain Med. 2023 Oct;42(5):101228. doi: 10.1016/j.accpm.2023.101228. Epub 2023 Apr 7.
- Individual participant dataSharing planned: No
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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.
Jean Yves LEFRANT principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Critical Illness and Intensive Care Unit, run by Centre Hospitalier Universitaire de Nīmes 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 1 inclusion and 0 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 4 Dec 2025. 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?
Evolution in mortality rate (time frame: from January 1st, 2013, to December 31st, 2019). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05353023, which also lists 1 linked publication.
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 4 Dec 2025.