Whole-body muscle electrical stimulation with amino acid support to protect muscle in ICU patients
The Effect of a Single Session of Whole-body Neuromuscular Electrical Stimulation (NMES), With or Without Subsequent Intake of an Amino Acid Bolus, on Whole-body Protein Turnover in Sedated Intensive Care Unit (ICU) Patients
This trial tests whether whole-body electrical muscle stimulation, with or without a 20 g amino acid bolus, helps maintain or build muscle protein in adults on mechanical ventilation in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wageningen University Academic / other |
| Locations | 1 site (Ede) |
| Trial ID | NCT07430969 on ClinicalTrials.gov |
What this trial studies
Mechanically ventilated ICU patients are randomized to receive sham stimulation with standard enteral nutrition, active whole-body neuromuscular electrical stimulation (NMES) with standard nutrition, or active NMES followed by a 20 g amino acid bolus. Participants receive continuous infusions of labeled amino acids to measure whole-body protein synthesis, breakdown, and net balance, along with blood sampling and upper-arm ultrasound to assess muscle blood flow. The primary outcome is whole-body protein net balance, with secondary outcomes including protein synthesis, breakdown, oxidation, and muscle glucose uptake. Interventions occur at the bedside while patients remain sedated and receiving enteral feeding.
Who should consider this trial
Good fit: Adults (≥18) in the ICU expected to need mechanical ventilation for at least 48 hours, sedated to RASS −4/−5, receiving gastric tube feeding, and with arterial and venous lines in place are ideal candidates.
Not a fit: Patients with contraindications to NMES (open wounds, spinal cord injury, burns, implanted pacemaker/ICD), those with advanced AKI or on continuous hemofiltration, pregnant patients, or those judged unsuitable by the intensivist are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could help preserve or increase muscle protein and reduce muscle wasting in ventilated ICU patients.
How similar studies have performed: Small prior studies suggest NMES can reduce muscle loss in some ICU patients but results are mixed and combining NMES with an amino acid bolus is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥18 years * Expected to need mechanical ventilation for at least 48 hours, judged by physician * Expected to reach a Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 (complete sedation), judged by physician * Informed consent obtained from the next-of-kin * Able to or are receiving gastric tube feeding * Have an arterial and a venous line in situ Exclusion Criteria: * Spinal cord injury * Previous surgery/local wounds that prohibit whole-body NMES * Conditions that prohibit NMES (such open wounds) * Chronic neuromuscular disorders (such as Amyotrophic lateral sclerosis (ALS)) * Acute Kidney Injury (AKI) II and III * Undergoing continuous veno-venous hemofiltration (CVVH) * Rhabdomyolysis * Neuromuscular blocking agents * In the caloric restriction period of refeeding syndrome * In prone position * Burn wounds * ICD/pacemaker * Pregnant * Deemed not suitable to participate based upon the judgement of the treating intensivist
Where this trial is running
Ede
- Hospital Gelderse Vallei — Ede, Netherlands (Recruiting)
Study contacts
- Study coordinator: Marlou Dirks, PhD
- Email: marlou.dirks@wur.nl
- Phone: +31 317 480 100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.