Prognostic Factors , Morbidity and Mortality in Patients With Neuromuscular Disorders Admitted in ICU

May 14, 2019 updated by: Abdallah FAYSSOIL, Centre d'Investigation Clinique et Technologique 805

Prognostic Factors, Morbidity, Mortality and Long Term Survival in Patients With Neuromuscular Disorders Admitted in Intensive Care Unit

Muscular dystrophies are neuromuscular disorders with disability. Restrictive pulmonary failure and cardiomyopathy affect prognosis.The investigators aim to establish predictive factors for mortality and morbidity in Intensive care unit (ICU ) and to describe the long term follow up after ICU discharge.

Study Overview

Status

Unknown

Conditions

Detailed Description

Muscular dystrophies are neuromuscular disorders with disability. Restrictive pulmonary failure and cardiomyopathy affect prognosis. Little is known about morbidity and mortality of patients with muscular dystrophies admitted in intensive care unit (ICU).The investigators aim to describe the spectrum of patients with muscular dystrophies admitted in ICU , to establish predictive factors for ICU mortality and morbidity and to describe the long term follow up after ICU discharge.

Study Type

Observational

Enrollment (Anticipated)

800

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
      • Garches, France, 92380
        • Hôpital Raymond Poincaré

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with neuro-muscular disorders admitted in ICU since 2005

Description

Inclusion Criteria:

  • admitted in ICU
  • Duchenne muscular dystrophy
  • Becker muscular dystrophy
  • LGMD
  • Steinert disease
  • Pompe disease
  • FSHD
  • metabolic disease
  • mitochondrial disease
  • congenital myopathy
  • others neuro-muscular diseases

Exclusion Criteria:

  • brain injury
  • minor patient

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
Time Frame
ICU mortality
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
tracheostomy in ICU
Time Frame: 1 month
1 month
predictive factors for re admission in ICU
Time Frame: 1 year
1 year
long term survival after ICU stay
Time Frame: 5 years
5 years
decline of vital capacity after ICU stay
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Centre d'Investigation Clinique et Technologique 805

Investigators

  • Principal Investigator: abdallah Fayssoil, MDPhD, Raymond Poincaré Hospital

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

March 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1912677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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