Critical Illness, Muscle Wasting
Conditions
Keywords
Leucine, Branched-chain amino acid, Muscle wasting, Critically-ill patients, Muscle thickness, Interleukin-6, Sequential organ failure assessment score
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.
Interventions
DIETARY_SUPPLEMENTBCAA
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
OTHERStandard nutrition
Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70
OTHERStandard 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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle thickness | 10 days | Quadriceps femoris dextra muscle thickness between groups at baseline and end of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-6 | 10 days | Interleukin-6 levels between groups at baseline and end of study |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sequential Organ Failure Assessment Score | 10 days | Sequential Organ Failure Assessment Score between groups at baseline and end of study on scale 0-24 |
Countries
Indonesia
Outcome results
None listed