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

Not Applicable

Completed

• Conditions: Critical Illness; Muscle Wasting
• Interventions: Dietary Supplement: BCAA; Other: Standard nutrition; Other: Standard physiotherapy

• Registration Number: NCT06167772
• Lead Sponsor: Indonesia University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-13
• Study Start: 2023-12-14
• Primary Completion: 2024-05-10
• Study Completion: 2024-05-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-21
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Branched-chain Amino Acid (BCAA) group	BCAA	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
Branched-chain Amino Acid (BCAA) group	Standard nutrition	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
Control group	Standard physiotherapy	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
Branched-chain Amino Acid (BCAA) group	Standard physiotherapy	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
Control group	Standard nutrition	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

Primary Outcome Measures

Name	Time	Method
Muscle thickness	10 days	Quadriceps femoris dextra muscle thickness between groups at baseline and end of study

Secondary Outcome Measures

Name	Time	Method
Interleukin-6	10 days	Interleukin-6 levels between groups at baseline and end of study

Trial Locations

Locations (2)

Dr. Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia

Universitas Indonesia Hospital; 🇮🇩 Depok, Jawa Barat, Indonesia