Admission of Adult-onset Still Disease Patients in the ICU | NCT03276650

Studies
Admission of Adult-onset Still Disease Patients in the ICU

NCT03276650

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Sep 20, 2018Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Adult-Onset Still Disease
Critically Ill

Interventions

data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Aug 1, 2018Actual

First Submitted Date

Aug 25, 2017

First Submission Date that Met QC Criteria

Sep 7, 2017

First Posted Date

Sep 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2018

Last Update Posted Date

Sep 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
critically ill AOSD patients		no intervention Data collection from hospitalisation reports (administrative, biological, clinical, outcome)	Other: data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
data collection	Other	biological, administrative, clinical, outcome date	critically ill AOSD patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult AOSD patients admitted to ICU

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU		Nancy		54000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016706	Still's Disease, Adult-Onset
D016638	Critical Illness

Ancestor Terms

ID	Term
D001172	Arthritis, Rheumatoid
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided