Admission of Adult-onset Still Disease Patients in the ICU

Critically Ill Clinical Trial

— Still-ICU  

Official title:

Admission of Adult-onset Still Disease Patients in the ICU: a French Retrospective Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276650
• Other study ID #: PSS2017/Still-ICU-LEMARIE/VS
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: September 2018
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• AOSD (history of newly diagnosed)

• ICU admission between January 2001 and June 2017

Exclusion Criteria:

• adults under protection

• admission in step-down unit

Related Conditions & MeSH terms

• Adult-Onset Still Disease
• Arthritis, Juvenile
• Critical Illness
• Critically Ill
• Still's Disease, Adult-Onset

Intervention

Other:
• data collection
biological, administrative, clinical, outcome date

Locations

Country	Name	City	State
France	CHRU	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients	Number of patients fulfilling the inclusion criteria	At inclusion
Secondary	APACHE II	Acute Physiologic Assessment and Chronic Health Evaluation II	24hour after ICU admission
Secondary	Mortality	Kaplan Meier	through study completion, maximum 17,5 years after admission
Secondary	Number of rehospitalisation in ICU	need for critical care after the first hospitalisation in ICU	through study completion, maximum 17,5 years after admission
Secondary	number of hospitalisation in internal medicine ward	number of hospitalisation in internal medicine ward after the first ICU stay	through study completion, maximum 17,5 years after admission
Secondary	recurrent relapses	number of recurrent flares after the first hospitalisation in ICU	through study completion, maximum 17,5 years after admission