Adult-Onset Still DiseaseStill-ICUNCT03276650
Admission of Adult-onset Still Disease Patients in the ICU
An observational study of Adult-Onset Still Disease and Critically Ill, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains challenging. Rarely, AOSD may present severe systemic manifestations and require intensive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult-Onset Still Disease, Critically Ill
- What is being tested?
- data collection
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to 1 Aug 2018
- 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: Adult AOSD patients admitted to ICU
Who may be able to join
- AOSD (history of newly diagnosed)
- ICU admission between January 2001 and June 2017
Who cannot join
- adults under protection
- admission in step-down unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Admission of Adult-onset Still Disease Patients in the ICU: a French Retrospective Multicentric Study
Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains challenging. Rarely, AOSD may present severe systemic manifestations and require intensive care. The main purpose of the Stil ICU study is to make the first description of the epidemiology of critically ill AOSD patients. The investigators will use a retrospective cohort study design with dual recruitment strategies: (1) via the AOSD referral centres network and (2) via a French academic medical ICU network.
- Conditions
- Adult-Onset Still Disease, Critically Ill
- Being tested
- data collection
- Medical subject headings
- Still's Disease, Adult-Onset, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
biological, administrative, clinical, outcome date
| Study group | Role | What they receive |
|---|---|---|
| critically ill AOSD patients | no intervention Data collection from hospitalisation reports (administrative, biological, clinical, outcome) Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients
Number of patients fulfilling the inclusion criteria
Measured: At inclusion
Secondary outcomes (5)
APACHE II
Acute Physiologic Assessment and Chronic Health Evaluation II
Measured: 24hour after ICU admission
Mortality
Kaplan Meier
Measured: through study completion, maximum 17,5 years after admission
Number of rehospitalisation in ICU
need for critical care after the first hospitalisation in ICU
Measured: through study completion, maximum 17,5 years after admission
number of hospitalisation in internal medicine ward
number of hospitalisation in internal medicine ward after the first ICU stay
Measured: through study completion, maximum 17,5 years after admission
recurrent relapses
number of recurrent flares after the first hospitalisation in ICU
Measured: through study completion, maximum 17,5 years after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Jun 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult-Onset Still DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276650
- Sponsor's protocol ID
- PSS2017/Still-ICU-LEMARIE/VS
- Acronym
- Still-ICU
- Status last verified
- Sep 2018
- First submitted
- 25 Aug 2017
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Admission of Adult-onset Still Disease Patients in the ICU: a French Retrospective Multicentric Study
- ClinicalTrials.gov ID
- NCT03276650
- Acronym / sponsor ID
- Still-ICU / PSS2017/Still-ICU-LEMARIE/VS
- Conditions
- Adult-Onset Still Disease, Critically Ill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 8 Sep 2017 (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.
Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains challenging. Rarely, AOSD may present severe systemic manifestations and require intensive care. The main purpose of the Stil ICU study is to make the first description of the epidemiology of critically ill AOSD patients. The investigators will use a retrospective cohort study design with dual recruitment strategies: (1) via the AOSD referral centres network and (2) via a French academic medical ICU network.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill AOSD patients | – | Other: data collectionno intervention Data collection from hospitalisation reports (administrative, biological, clinical, outcome) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult AOSD patients admitted to ICU
Key inclusion criteria (2 listed)
- AOSD (history of newly diagnosed)
- ICU admission between January 2001 and June 2017
Key exclusion criteria (2 listed)
- adults under protection
- admission in step-down unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionbiological, administrative, clinical, outcome date | Other | critically ill AOSD patients |
Primary outcome
number of patients
Time frame: At inclusion
Number of patients fulfilling the inclusion criteria
5 secondary outcomes
APACHE II
Time frame: 24hour after ICU admission
Mortality
Time frame: through study completion, maximum 17,5 years after admission
Number of rehospitalisation in ICU
Time frame: through study completion, maximum 17,5 years after admission
number of hospitalisation in internal medicine ward
Time frame: through study completion, maximum 17,5 years after admission
recurrent relapses
Time frame: through study completion, maximum 17,5 years after admission
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 20 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adult-Onset Still Disease and Critically Ill, run by Central Hospital, Nancy, France 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 2 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 20 Sep 2018. 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?
number of patients (time frame: At inclusion). 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 20 Sep 2018.