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The Effect of Muscle Stimulation and Amino Acid Intake on Protein Metabolism During Critical Illness

ConditionMuscle Wasting in Critically Ill
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWageningen University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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))

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sham (No Treatment)

    Other intervention

    A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES.

  • NMES

    Other intervention

    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.

  • Standard enteral nutrition

    Other intervention

    The provision of standard nutritional support, typically administered via enteral feeding tubes.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Control groupSham comparator 2 interventions
Group B: Whole-body NMES groupActive comparator 2 interventions
Group C: Whole-body NMES + protein groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Whole-body protein net balance (WPNB)

WPNB prior to and following NMES (and protein bolus intake)

Time frame
7.5 hours

Secondary outcomes

1

Forearm glucose uptake

Insulin sensitivity, measured as forearm glucose uptake, prior to and following NMES (and protein bolus intake)

Time frame
7.5 hours
2

Forearm amino acid kinetics

Plasma phenylalanine and tyrosine kinetics using a stable isotope tracer infusion

Time frame
7.5 hours
3

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.

Time frame
9.5 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wageningen University

Lead sponsor

Gelderse Vallei Hospital

Collaborator

Source ClinicalTrials.gov
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