NCT02685215

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 14, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

3.8 years

First QC Date

January 14, 2016

Last Update Submit

May 14, 2019

Conditions

Muscular DystrophiesIntensive Care (ICU) Myopathy

Keywords

intensive care unitmuscular dystrophymortalityprognosistracheostomy

Outcome Measures

Primary Outcomes (1)

  • ICU mortality

    1 month

Secondary Outcomes (4)

  • tracheostomy in ICU

    1 month

  • predictive factors for re admission in ICU

    1 year

  • long term survival after ICU stay

    5 years

  • decline of vital capacity after ICU stay

    2 years

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

  • brain injury
  • minor patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, 92380, France

Location

MeSH Terms

Conditions

Muscular DystrophiesMuscular Diseases

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • abdallah Fayssoil, MDPhD

    Raymond Poincare Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 14, 2016

First Posted

February 18, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)