Admission of Adult-onset Still Disease Patients in the ICU

NCT03276650 | Completed

• 1 other identifier: PSS2017/Still-ICU-LEMARIE/VS
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adult-Onset Still Disease; Critically Ill

Outcome Measures

Primary Outcomes (1)

• number of patients

  Number of patients fulfilling the inclusion criteria

  At inclusion

Secondary Outcomes (5)

• APACHE II

  24hour after ICU admission

• Mortality

  through study completion, maximum 17,5 years after admission

• Number of rehospitalisation in ICU

  through study completion, maximum 17,5 years after admission

• number of hospitalisation in internal medicine ward

  through study completion, maximum 17,5 years after admission

• recurrent relapses

  through study completion, maximum 17,5 years after admission

Study Arms (1)

critically ill AOSD patients

no intervention Data collection from hospitalisation reports (administrative, biological, clinical, outcome)

Other: data collection

Interventions

data collection OTHER

biological, administrative, clinical, outcome date

critically ill AOSD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult AOSD patients admitted to ICU

You may qualify if:

• AOSD (history of newly diagnosed)
• ICU admission between January 2001 and June 2017

You may not qualify if:

• adults under protection
• admission in step-down unit

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU

Nancy, 54000, France

Location

MeSH Terms

Conditions

Still's Disease, Adult-Onset; Critical Illness

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: September 8, 2017
• Study Start: September 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)