Skip to main content
OpenTrials
Completed

NCT Number: NCT06167772

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Cipto Mangunkusumo Hospital, Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCAA

Dietary Supplement

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

Other

Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70

Other names: High protein oral nutritional supplementation

Standard Physiotherapy

Other

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.

Other names: Neuromuscular electrical stimulation

Primary outcomes

  1. Muscle thickness

    Time frame: 10 days

    Quadriceps femoris dextra muscle thickness between groups at baseline and end of study

Secondary outcomes

  1. Interleukin-6

    Time frame: 10 days

    Interleukin-6 levels between groups at baseline and end of study

Other outcomes

  1. Sequential Organ Failure Assessment Score

    Time frame: 10 days

    Sequential Organ Failure Assessment Score between groups at baseline and end of study on scale 0-24

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Acronym: SOFA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.