ß-Hydroxy-ß-Methylbutrate (HMB) supplementation and functiOnal OutcomeS in multi-Trauma patients (BOOST TRIAL)

Not Applicable

Completed

• Conditions: Multi-trauma; Critical Illness; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12620001305910
• Lead Sponsor: The Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-02
• Study Completion: 2022-11-30
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

a.Adults, 18 years of age and older
b.Completed two full calendar days in ICU
c.The predominant reason for ICU admission was a traumatic injury
d.Allowed enteral/ oral nutrition at the time of randomization

Inclusion criteria for the muscle biopsy sub group as above.

Exclusion Criteria

a. Death during ICU admission deemed to be inevitable
b. Bilateral above knee amputation
c. Patients assessed as requiring completely or predominantly parenteral nutrition
d. Pregnancy
e. Primary neuromuscular pathology present or strongly suspected this admission episode
f. Presumed transection of the spinal cord at any level
g. Medical decision treatment maker, participant or medical practitioner declined consent
h. Limited research availability over enrolment timeframe
I. Enrollment conflict with other research studies
j. Unlikely to be able to participate in long term follow up measures
k. Unable to obtain consent within 7 days from initial traumatic injury

Additional exclusion criteria for the muscle biopsy sub-group:
g.Not mechanically ventilated at the time of enrollment or predicted to be extubated within 48 hours of enrollment.
h.Present or strongly suspected disseminated cancer of any kind
i.Bleeding diathesis (corrected INR > 1.5 and/or APTT > 50 sec), or receiving any anticoagulant medication beyond that required for venous thromboembolism prophylaxis, or any antiplatelet drug other than low dose aspirin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful blinding of the intervention determined through patient and clinician surveys. <br>[ Blinding surveys (patient and clinician) will be completed on day 1 and again at hospital discharge. ];Recruitment and retention rates will be analysed for patients who meet all inclusion and none of the exclusion criteria at completion of the study. [ Recruitment and retention will be assessed once the last participant has completed the final outcome measure. ];The amount of HMB supplementation actually administered compared to the amount intended with full protocol compliance.[ Assessed daily from via the medication administration record documented by nursing staff in the medical record from recruitment until hospital discharge or day 28 of the study. ]