Systemic Rheumatic DiseasesProSyDICUNCT04398381
Prognosis of SRD Patients in the ICU
An observational study of Systemic Rheumatic Diseases and Intensive Care Unit, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Critically ill systemic rheumatic disease (SRD) patients have benefited from better provision of rheumatic and critical care in recent years. Recent comprehensive data regarding in-hospital mortality and most importantly long-term outcome are scarce. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Systemic Rheumatic Diseases, Intensive Care Unit, Corticosteroids
- How many people
- 525 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 30 Jun 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive SRD patients admitted to ICUs during the study period
Who may be able to join
- All consecutive SRD patients admitted to ICUs during the study period
- at least one urine sample
Who cannot join
- Age < 18 years
- Persons under protection
- Paritcipation rejections
- Admition to the ICU after scheduled surgery or trauma or suicide attempt unrelated to neurological involvement of SRD
- Cancer treated with chemotherapy within a month before ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-year Outcome of Critically Ill Patients With Systemic Rheumatic Disease: a Multicenter Cohort Study
Critically ill systemic rheumatic disease (SRD) patients have benefited from better provision of rheumatic and critical care in recent years. Recent comprehensive data regarding in-hospital mortality and most importantly long-term outcome are scarce. The aim of this study is to assess short and long-term outcome of patients with SRD admitted to the ICU in a retrospective cohort study (2006 - 2016).
- Keywords
- outcomes, prognostic factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate in the ICU associated risk factors
Mortality rate in the ICU associated risk factors
Measured: 1 day
Secondary outcomes (1)
Mortality rate in the hospital and one-year after ICU admission and associated risk factors
Mortality rate in the hospital and one-year after ICU admission and associated risk factors
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Mar 2017
- Primary completion1 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Sorbonne University, Hôpital Lariboisière Fernand Widal, Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Romaric Larcher, MD PhD, Study director, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398381
- Sponsor's protocol ID
- RECHMPL18_0289
- Acronym
- ProSyDICU
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Outcome of Critically Ill Patients With Systemic Rheumatic Disease: a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04398381
- Acronym / sponsor ID
- ProSyDICU / RECHMPL18_0289
- Keywords
- outcomes, prognostic factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Sorbonne University, Hôpital Lariboisière Fernand Widal, Université Montpellier
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 21 May 2020 (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.
Critically ill systemic rheumatic disease (SRD) patients have benefited from better provision of rheumatic and critical care in recent years. Recent comprehensive data regarding in-hospital mortality and most importantly long-term outcome are scarce. The aim of this study is to assess short and long-term outcome of patients with SRD admitted to the ICU in a retrospective cohort study (2006 - 2016).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive SRD patients admitted to ICUs during the study period
Key inclusion criteria (2 listed)
- All consecutive SRD patients admitted to ICUs during the study period
- at least one urine sample
Key exclusion criteria (5 listed)
- Age < 18 years
- Persons under protection
- Paritcipation rejections
- Admition to the ICU after scheduled surgery or trauma or suicide attempt unrelated to neurological involvement of SRD
- Cancer treated with chemotherapy within a month before ICU admission
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 rate in the ICU associated risk factors
Time frame: 1 day
Mortality rate in the ICU associated risk factors
1 secondary outcome
Mortality rate in the hospital and one-year after ICU admission and associated risk factors
Time frame: 1 day
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 28 May 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Romaric Larcher, MD PhD study director
UH Montpellier
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 Systemic Rheumatic Diseases and Intensive Care Unit, run by University Hospital, Montpellier 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 5 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 28 May 2020. 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 rate in the ICU associated risk factors (time frame: 1 day). 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 28 May 2020.