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Clinical Trials/NCT06167772
NCT06167772CompletedNot Applicable

Effects of Leucine-enriched Branched-chain Amino Acid on Muscle Thickness, Interleukin-6, and Sequential Organ Failure Assessment Score in Critically Ill Patients

Indonesia University3 sites in 1 country40 target enrollmentStarted: December 14, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

dr. Yohannessa Wulandari, M.Gizi, Sp GK

Principal Investigator, Clinical nutrition specialist; PhD student

Indonesia University

Study Sites (3)

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