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Trial record 52 of 5217 for:    neuromuscular disease

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

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ClinicalTrials.gov Identifier: NCT02685215
Recruitment Status : Active, not recruiting
First Posted : February 18, 2016
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Abdallah FAYSSOIL, Centre d'Investigation Clinique et Technologique 805

Brief Summary:
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.

Condition or disease
Muscular Dystrophies Intensive Care (ICU) Myopathy

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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Prognostic Factors, Morbidity, Mortality and Long Term Survival in Patients With Neuromuscular Disorders Admitted in Intensive Care Unit
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. ICU mortality [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. tracheostomy in ICU [ Time Frame: 1 month ]
  2. predictive factors for re admission in ICU [ Time Frame: 1 year ]
  3. long term survival after ICU stay [ Time Frame: 5 years ]
  4. decline of vital capacity after ICU stay [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with neuro-muscular disorders admitted in ICU since 2005
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685215


Locations
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France
Hopital Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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Principal Investigator: abdallah Fayssoil, MDPhD Raymond Poincare Hospital

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Responsible Party: Abdallah FAYSSOIL, MD PhD, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02685215     History of Changes
Other Study ID Numbers: 1912677
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abdallah FAYSSOIL, Centre d'Investigation Clinique et Technologique 805:
intensive care unit
muscular dystrophy
mortality
prognosis
tracheostomy
Additional relevant MeSH terms:
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Muscular Dystrophies
Neuromuscular Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Genetic Diseases, Inborn