MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients
Recruiting
N/A
Interventional Study
Sepsis
Critical Illness
ICU-acquired Muscle Weakness
ICU-acquired Weakness
ICUAW
Sarcopenia
Secondary Sarcopenia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 50 (estimated)
- Sponsor
- Health Discovery Labs · Industry
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About This Trial
The goal of this clinical trial is to learn if a new medical device that sends electrical signals to the thigh muscles is safe and easy to use for people in the ICU (Intensive Care Unit) who are at risk of losing muscle strength. It will also explore whether this treatment can help slow down muscle weakening.
The main questions this study aims to answer are:
* Do participants develop medical pro…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Admitted to ER or ICU within the previous 48 hours
* APACHE II score ≥ 13
* Meets the criteria for sepsis or severe sepsis
Exclusion Criteria:
* Anticipated transfer to an ICU not participating in this study
* Myopathies (e.g. congenital)
* Acquired myopathies with CK levels…
Contacts