Leucine-enriched Branched-chain Amino Acid on Muscle Thickness, Interleukin-6, SOFA Score in Critical Illness

Study Overview
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Brief Summary
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The goal of this clinical trial study is to test effects of leucine-enriched branched-chain amino acid (BCAA) in critically ill patients. The main questions it aims to answer are: • How are the changes in muscle thickness between groups at baseline and end of study • Is there a decrease in interleukin-6 levels between groups at baseline and end of study • Is there a decrease in sequential organ failure assessment score between groups at baseline and end of study. Participants will be given leucine-enriched branched-chain amino acid 40 g/day enterally or parenterally for 10 days. Researchers will compare with control groups to see if there is any changes between groups at baseline and end of study.

Detailed Description
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The goal of this clinical trial study is to test effects of leucine-enriched branched-chain amino acid (BCAA) in critically ill patients. The main questions it aims to answer are: • How are the changes in muscle thickness between groups at baseline and end of study • Is there a decrease in interleukin-6 levels between groups at baseline and end of study • Is there a decrease in sequential organ failure assessment score between groups at baseline and end of study. Participants will be given leucine-enriched branched-chain amino acid 40 g/day enterally or parenterally for 10 days. Researchers will compare with control groups to see if there is any changes between groups at baseline and end of study. Both groups will be given standard nutrition with target energy of 20 kcal/kg bodyweight(BW)/day and ratio of nitrogen:non-protein calorie 1:70 and neuromuscular electrical stimulation 30 minutes per day.

Official Title
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Effects of Leucine-enriched Branched-chain Amino Acid on Muscle Thickness, Interleukin-6, and Sequential Organ Failure Assessment Score in Critically Ill Patients

Conditions
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Critical Illness, Muscle Wasting

Intervention / Treatment
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* Dietary Supplement: BCAA
* Other: Standard nutrition
* Other: Standard physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: new admission to intensive care unit (ICU) in first 24 hours aged 18-65 years SOFA score >= 4 Exclusion Criteria: pregnant ultrasound examination cannot be performed under these circumstances: deformities, open wounded, prosthetics on right leg, amputated above right patella body mass index <16 kg/m2 chronic kidney disease stage 3-5 diabetes mellitus uncontrolled blood glucose (BG) (BG >200 mg/dL) neuromuscular diseases with musculus quadriceps femoris dextra paralysis autoimmune diseases referral from another ICU

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Branched-chain Amino Acid (BCAA) group<br>branched-chain amino acid (bcaa) (ratio valine:leucine:isoleucine = 1.2:2:1) 40 g/day (leucine 19 g/day) form: powdered bcaa sealed in 8 g sachet package or bcaa parenteral 250 mL per bag. frequency: 1 sachet bcaa dissolved in oral nutrition supplement (standard nutrition) 5 times per day, or bcaa parenteral, or combination of bcaa enteral & parenteral. duration: 10 days standard nutrition: oral nutrition supplement (high protein) or parenteral with target energy of 20 kcal/kg BW/day standard neuromuscular electrical stimulation 30 minutes per day | Dietary Supplement: BCAA<br>* branched-chain amino acid (bcaa) (ratio valine:leucine:isoleucine = 1.2:2:1) 40 g/day (leucine 19 g/day) form: powdered bcaa sealed in 8 g sachet package or bcaa parenteral 250 mL per bag. frequency: 1 sachet bcaa dissolved in oral nutrition supplement (standard nutrition) 5 times per day, or bcaa parenteral, or combination of bcaa enteral & parenteral. duration: 10 days<br>Other: Standard nutrition<br>* Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70<br>* Other names: High protein oral nutritional supplementation;Other: Standard physiotherapy<br>* A symmetric biphasic rectangular pulse was employed, with a frequency of 100 Hz, pulse width of 500 µs, Ton 5 s, Toff 25 s, ramp up of 1 s and ramp down of 1 s.<br>* Other names: Neuromuscular electrical stimulation;|
| Placebo Comparator: Control group<br>No placebo. Not given intervention product. standard nutrition: oral nutrition supplement (high protein) or parenteral with target energy of 20 kcal/kg BW/day standard neuromuscular electrical stimulation 30 minutes per day | Other: Standard nutrition<br>* Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70<br>* Other names: High protein oral nutritional supplementation;Other: Standard physiotherapy<br>* A symmetric biphasic rectangular pulse was employed, with a frequency of 100 Hz, pulse width of 500 µs, Ton 5 s, Toff 25 s, ramp up of 1 s and ramp down of 1 s.<br>* Other names: Neuromuscular electrical stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle thickness | Quadriceps femoris dextra muscle thickness between groups at baseline and end of study | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 | Interleukin-6 levels between groups at baseline and end of study | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leucine, Branched-chain amino acid, Muscle wasting, Critically-ill patients, Muscle thickness, Interleukin-6, Sequential organ failure assessment score