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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-14

Study Completion Date

2024-05-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness Muscle Wasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Branched-chain Amino Acid (BCAA) group

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 standard nutrition: oral nutrition supplement (high protein) or parenteral with target energy of 20 kcal/kg BW/day standard neuromuscular electrical stimulation 30 minutes per day

Group Type EXPERIMENTAL

BCAA

Intervention Type DIETARY_SUPPLEMENT

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

Standard nutrition

Intervention Type OTHER

Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70

Standard physiotherapy

Intervention Type OTHER

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.

Control group

No placebo. Not given intervention product. standard nutrition: oral nutrition supplement (high protein) or parenteral with target energy of 20 kcal/kg BW/day standard neuromuscular electrical stimulation 30 minutes per day

Group Type PLACEBO_COMPARATOR

Standard nutrition

Intervention Type OTHER

Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70

Standard physiotherapy

Intervention Type OTHER

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.

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Standard nutrition

Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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High protein oral nutritional supplementation Neuromuscular electrical stimulation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No