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

Muscular Dystrophies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02685215
• Other study ID #: 1912677
• Status: Active, not recruiting
• Start date: March 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care (ICU) Myopathy
• Muscular Dystrophies
• Neuromuscular Diseases

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU mortality		1 month
Secondary	tracheostomy in ICU		1 month
Secondary	predictive factors for re admission in ICU		1 year
Secondary	long term survival after ICU stay		5 years
Secondary	decline of vital capacity after ICU stay		2 years