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NCT07430969
The Effect of Muscle Stimulation and Amino Acid Intake on Protein Metabolism During Critical Illness
Conditions: Muscle Wasting in Critically Ill
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Wageningen University
Location: Hospital Gelderse Vallei Ede
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
Eligibility 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
Source: ClinicalTrials.gov (NCT07430969). StuddyBuddy aggregates publicly available trial information.