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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06167772
Other study ID # 23-09-1478
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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