Admission of Adult-onset Still Disease Patients in the ICU (Still-ICU)

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill; Adult-Onset Still Disease
• Intervention / Treatment: Other: data collection

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • CHRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult AOSD patients admitted to ICU

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
critically ill AOSD patients; no intervention Data collection from hospitalisation reports (administrative, biological, clinical, outcome)	Other: data collection; biological, administrative, clinical, outcome date

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients	Number of patients fulfilling the inclusion criteria	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APACHE II	Acute Physiologic Assessment and Chronic Health Evaluation II	24hour after ICU admission
Mortality	Kaplan Meier	through study completion, maximum 17,5 years after admission
Number of rehospitalisation in ICU	need for critical care after the first hospitalisation in ICU	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	through study completion, maximum 17,5 years after admission
recurrent relapses	number of recurrent flares after the first hospitalisation in ICU	through study completion, maximum 17,5 years after admission

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (ACTUAL): September 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Critical Illness; Arthritis, Juvenile; Still's Disease, Adult-Onset
• Other Study ID Numbers: PSS2017/Still-ICU-LEMARIE/VS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No