NCT06167772

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness
• Muscle Wasting

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
OTHER	Standard nutrition	Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70
OTHER	Standard physiotherapy	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.

Timeline

• Start date: 2023-12-14
• Primary completion: 2024-05-10
• Completion: 2024-05-10
• First posted: 2023-12-13
• Last updated: 2024-07-23

Locations

2 sites across 1 country: Indonesia