Intensive Care Unit-acquired weakness (ICUAW)/Critical illness myopathy (CIM) Musculoskeletal Diseases Other myopathies
Conditions
Interventions
Current intervention as of 15/10/2021:
Patients allocated to the intervention group will receive EMS treatment of M. quadriceps femoris (M. vastus lateralis and M. rectus femoris), M.
Sponsors
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical: muscle strength assessd by MRC score after the end of sedation and functional impairment at ICU discharge as indicated by FIM 2. Molecular: incidence of histologically proven CIM, measured during the study enrolment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical (assessed during the study enrolment period): 1.1. Ventilator-free days 1.2. ICU stay 1.3. EMG/ENG 1.4. Weaning failure 2. Molecular (analysed once patient enrolment has ended): 2.1. Signalling pathways (insulin/IGF-1, AMP-Kinase, MAP-Kinase) 2.2. Tissue metabolism 2.3. Atrophy gene regulation 2.4. Mitochondrial function 2.5. Caveolae dynamics | — |
Countries
Germany
Outcome results
None listed