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

Critical Illness Clinical Trial

— SOFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06167772
• Other study ID #: 23-09-1478
• Status: Completed
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: May 10, 2024

Study information

• Verified date: May 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Critical Illness
• Muscle Wasting
• Muscular Atrophy

Intervention

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
• 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.

Locations

Country	Name	City	State
Indonesia	Universitas Indonesia Hospital	Depok	Jawa Barat
Indonesia	Dr. Cipto Mangunkusumo Hospital	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sequential Organ Failure Assessment Score	Sequential Organ Failure Assessment Score between groups at baseline and end of study on scale 0-24	10 days
Primary	Muscle thickness	Quadriceps femoris dextra muscle thickness between groups at baseline and end of study	10 days
Secondary	Interleukin-6	Interleukin-6 levels between groups at baseline and end of study	10 days