Prognosis of SRD Patients in the ICU | NCT04398381

Studies
Prognosis of SRD Patients in the ICU

NCT04398381

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

May 28, 2020Actual

Enrollment

525Actual

Phase

Not provided

Conditions

Systemic Rheumatic Diseases
Intensive Care Unit
Corticosteroids

Interventions

Not provided

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

May 2020

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

Mar 1, 2017Actual

Primary Completion Date

Jun 1, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

May 18, 2020

First Submission Date that Met QC Criteria

May 18, 2020

First Posted Date

May 21, 2020Actual

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

May 26, 2020

Last Update Posted Date

May 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospital, MontpellierOTHER

Collaborators

Name	Class
Groupe Hospitalier Pitie-Salpetriere	OTHER
Sorbonne University	OTHER
Hôpital Lariboisière Fernand Widal	OTHER
Université Montpellier

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

Critically ill systemic rheumatic disease (SRD) patients have benefited from better provision of rheumatic and critical care in recent years. Recent comprehensive data regarding in-hospital mortality and most importantly long-term outcome are scarce. The aim of this study is to assess short and long-term outcome of patients with SRD admitted to the ICU in a retrospective cohort study (2006 - 2016).

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

525Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality rate in the ICU associated risk factors	Mortality rate in the ICU associated risk factors	1 day

Secondary Outcomes

Measure	Description	Time Frame
Mortality rate in the hospital and one-year after ICU admission and associated risk factors	Mortality rate in the hospital and one-year after ICU admission and associated risk factors	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

All consecutive SRD patients admitted to ICUs during the study period
at least one urine sample

Exclusion criteria:

Age < 18 years
Persons under protection
Paritcipation rejections
Admition to the ICU after scheduled surgery or trauma or suicide attempt unrelated to neurological involvement of SRD
Cancer treated with chemotherapy within a month before ICU admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

All consecutive SRD patients admitted to ICUs during the study period

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Romaric Larcher, MD PhD	UH Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided