Effects of Leucine-enriched Branched-chain Amino Acid on Muscle Thickness, Interleukin-6, and Sequential Organ Failure Assessment Score in Critically Ill Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indonesia University
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Muscle thickness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Outcomes
Primary Outcomes
Muscle thickness
Time Frame: 10 days
Quadriceps femoris dextra muscle thickness between groups at baseline and end of study
Secondary Outcomes
- Interleukin-6(10 days)
Investigators
dr. Yohannessa Wulandari, M.Gizi, Sp GK
Principal Investigator, Clinical nutrition specialist; PhD student
Indonesia University