Muscle Wasting in Critically Ill
Conditions
Keywords
NMES, Skeletal Muscle Metabolism, Protein, ICU
Brief summary
The goal of this clinical trial is to study how whole-body electrical stimulation combined with amino acid intake affects muscle health in ventilated ICU patients. The main questions to answer are: * Does electrostimulation improve the balance of muscle protein in ICU patients? * Does combining electrostimulation with amino acid help build muscle and prevent muscle loss? Researchers will compare three groups of patients: 1. Sham electrostimulation (no current applied) + the standard nutrition 2. Electrostimulation + the standard nutrition 3. Electrostimulation + a 20g amino acid bolus Participants will: * Receive either real or sham electrostimulation * Get their standard nutrition or a 20g amino acid bolus * Have marked amino acids given through an IV * Have blood samples taken to measure the amino acids and glucose in the blood * Undergo ultrasound of the upper arm to measure the blood flow
Detailed description
This clinical trial aims to investigate the effects of whole-body neuromuscular electrical stimulation (NMES) on muscle protein metabolism in mechanically ventilated ICU patients. The study will examine whether NMES, combined with or without amino acid intake, can positively affect muscle protein synthesis and help prevent muscle wasting, which is a common issue in critically ill patients. ICU patients often experience muscle wasting due to prolonged immobility and impaired muscle protein metabolism. Participants will be randomly assigned to one of three groups: 1. Sham-NMES + Standard Enteral Nutrition (CON): In this group, participants will receive sham NMES (inactive stimulation) followed by standard nutritional support. 2. Whole-body NMES + Standard Enteral Nutrition (WB-NMES): This group will receive active whole-body NMES followed by standard nutritional support. 3. Whole-body NMES + 20g Amino Acid Bolus (WB-NMES+AA): Participants in this group will receive active whole-body NMES followed by a 20g bolus of amino acids. The main goal of the study is to measure whole-body protein net balance (WPNB), which is the difference between muscle protein synthesis and muscle protein breakdown. Secondary outcomes include measuring whole-body protein synthesis, protein breakdown, protein oxidation, and muscle glucose uptake, a key indicator of muscle insulin sensitivity. To assess these outcomes, participants will receive a continuous intravenous infusion of labelled amino acids, and their blood will be sampled at various points. Doppler ultrasound will be used to measure amino acid and glucose balances in the forearm muscles. This study is crucial for understanding how NMES combined with amino acid intake can improve muscle health and metabolic function in ICU patients, potentially leading to better clinical outcomes, such as reduced muscle wasting and improved recovery during and after an ICU stay.
Interventions
OTHERSham (No Treatment)
A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES.
OTHERNMES
Active neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents.
DIETARY_SUPPLEMENTAmino acid bolus (20g)
A bolus dose of 20 grams of amino acids provided after the NMES intervention to assess the combined effect of muscle stimulation and protein intake on muscle protein metabolism.
The provision of standard nutritional support, typically administered via enteral feeding tubes.
Sponsors
Wageningen University
Gelderse Vallei Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A single test day during which participants will either receive sham- NMES followed by standard enteral nutrition (CON), whole-body NMES stimulation followed by standard enteral nutrition (WB-NMES), or whole-body NMES followed by a bolus of 20g amino acids (WB- NMES+AA). Continuous intravenous infusion of labelled amino acids will be combined with repeated blood samples.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole-body protein net balance (WPNB) | 7.5 hours | WPNB prior to and following NMES (and protein bolus intake) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forearm glucose uptake | 7.5 hours | Insulin sensitivity, measured as forearm glucose uptake, prior to and following NMES (and protein bolus intake) |
| Forearm amino acid kinetics | 7.5 hours | Plasma phenylalanine and tyrosine kinetics using a stable isotope tracer infusion |
| Splanchnic extraction | 9.5 hours | The process of removing substances from the blood circulating through the abdominal organs, such as the liver, intestines and spleen. Used to allow correction for splanchnic extraction of enteral amino acids. |
Countries
Netherlands
Contacts
CONTACTMarlou Dirks, PhD
Outcome results
None listed