Prognosis of SRD Patients in the ICU (ProSyDICU)

May 26, 2020 updated by: University Hospital, Montpellier

One-year Outcome of Critically Ill Patients With Systemic Rheumatic Disease: a Multicenter Cohort Study

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

525

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive SRD patients admitted to ICUs during the study period

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

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

Investigators

  • Study Director: Romaric Larcher, MD PhD, UH Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL18_0289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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