NCT04398381

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
525

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

2.3 years

First QC Date

May 18, 2020

Last Update Submit

May 26, 2020

Conditions

Systemic Rheumatic DiseasesIntensive Care UnitCorticosteroids

Keywords

outcomesprognostic factors

Outcome Measures

Primary Outcomes (1)

  • Mortality rate in the ICU associated risk factors

    Mortality rate in the ICU associated risk factors

    1 day

Secondary Outcomes (1)

  • Mortality rate in the hospital and one-year after ICU admission and associated risk factors

    1 day

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive SRD patients admitted to ICUs during the study period

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

  • Romaric Larcher, MD PhD

    UH Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 21, 2020

Study Start

March 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 30, 2019

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations

FR(1)