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Critical illness myopathy and timely electrical muscle stimulatio

Not Applicable
Completed
Conditions
Intensive Care Unit-acquired weakness (ICUAW)/Critical illness myopathy (CIM)
Musculoskeletal Diseases
Other myopathies
Registration Number
ISRCTN19392591
Lead Sponsor
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31016887 results (added 12/09/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31506074 results (added 12/09/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35922829/ Retrospective analysis (added 04/08/2022)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
50
Inclusion Criteria

1. Adults with a Sequential Organ Failure Assessment (SOFA) score greater than or equal to 9
2. Mechanical ventilation
3. Written informed consent of legal proxy
4. Aged greater than 18 years, either sex

Exclusion Criteria

1. Patients with mechanical ventilation and SOFA less than or equal to 9 for more than 72 hours prior study screening
2. Age less than 18 years
3. No written informed consent by legal proxy
4. Pre-existing neuromuscular disorder
5. Coagulation disorder refractory to therapy
6. Pregnancy
7. Poor prognosis with expected death within the next hours or days

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<br> 1. Clinical: muscle strength assessd by MRC score after the end of sedation and functional impairment at ICU discharge as indicated by FIM<br> 2. Molecular: incidence of histologically proven CIM, measured during the study enrolment period<br>
Secondary Outcome Measures
NameTimeMethod
<br> 1. Clinical (assessed during the study enrolment period):<br> 1.1. Ventilator-free days<br> 1.2. ICU stay<br> 1.3. EMG/ENG<br> 1.4. Weaning failure<br> 2. Molecular (analysed once patient enrolment has ended):<br> 2.1. Signalling pathways (insulin/IGF-1, AMP-Kinase, MAP-Kinase)<br> 2.2. Tissue metabolism<br> 2.3. Atrophy gene regulation<br> 2.4. Mitochondrial function<br> 2.5. Caveolae dynamics<br>
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