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| Name | Class |
|---|---|
| Gelderse Vallei Hospital | OTHER |
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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:
Researchers will compare three groups of patients:
Participants will:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | Sham-NMES with standard enteral nutrition |
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| Whole-body NMES group | Active Comparator | Whole-body NMES stimulation with standard enteral nutrition |
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| Whole-body NMES + protein group | Active Comparator | Whole-body NMES followed by a 20g amino acid bolus on top of the standard nutrition |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham (No Treatment) | Other | A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES. |
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| Measure | Description | Time Frame |
|---|---|---|
| Whole-body protein net balance (WPNB) | WPNB prior to and following NMES (and protein bolus intake) | 7.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Forearm glucose uptake | Insulin sensitivity, measured as forearm glucose uptake, prior to and following NMES (and protein bolus intake) | 7.5 hours |
| Forearm amino acid kinetics | Plasma phenylalanine and tyrosine kinetics using a stable isotope tracer infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marlou Dirks, PhD | Contact | +31 317 480 100 | marlou.dirks@wur.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Gelderse Vallei | Recruiting | Ede | Netherlands |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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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.
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| NMES | Other | Active neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents. |
|
| Amino acid bolus (20g) | Dietary Supplement | 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. |
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| Standard enteral nutrition | Other | The provision of standard nutritional support, typically administered via enteral feeding tubes. |
|
| 7.5 hours |
| Splanchnic extraction | 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. | 9.5 hours |