Clinical trial NCT06167772: Leucine-enriched Branched-chain Amino Acid on Muscle Thickness, Interleukin-6, SOFA Score in Critical Illness
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Muscle Wasting
Keywords: Leucine
Branched-chain amino acid
Muscle wasting
Critically-ill patients
Muscle thickness
Interleukin-6
Sequential organ failure assessment score
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle thickness
timeFrame: 10 days
Secondary outcomes:
measure: Interleukin-6
timeFrame: 10 days
Other outcomes:
measure: Sequential Organ Failure Assessment Score
timeFrame: 10 days
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo Hospital
state: Jakarta
city: Depok
country: Indonesia
facility: Universitas Indonesia Hospital
state: Jawa Barat
Study officials:
References: