Skip to main content

Table 2 Study schedule and outcome measure

From: β-Hydroxy-β-methylbutyrate (HMB) supplementation and functional outcomes in multi-trauma patients: a study protocol for a pilot randomised clinical trial (BOOST trial)

 

Assessment/Procedure

Screening and enrolment (day 0)

Day 1, then weekly until day 28 or hospital D/C

Daily from day 1–day 28 or hospital D/C

Day 1

Day 0 until ICU D/C and then 7 days post ICU D/C

ICU D/C

Day 28 or hospital D/C

Day 90 post enrolment

Study procedures

Informed consent

X

       

Demographic data, APACHE II, ANZROD and ISS, baseline creatinine and urea

X

       

Anthropometric data (weight, height and BMI)

X

       

Body weight

 

X

     

X

Nutrition status (SGA)

X

     

X

X

Muscle mass

 

X

     

X

Handgrip strength

 

X

     

X

Physical function (IMS and mILOA)

     

X

X

 

Physical function (PFIT-s)

     

X

  

Patient-reported appetite

 

X

     

X

Nutrition intake

    

X

   

Administration of intervention/control

  

X

     

Blinding survey

   

X

  

X

 

ICU LOS, days of mechanical ventilation, hospital LOS, discharge destination, use of renal replacement therapy, highest creatinine and urea

      

X

 

Quality of life survey

       

X

Place of residence and employment status

X

      

X

Mortality

      

X

X

  1. ANZROD Australian and New Zealand Risk of Death score, APACHE II Acute Physiology, Age, Chronic Health Evaluation II, BMI body mass index, IMS ICU Mobility Scale, ISS Injury Severity Scale, LOS length of stay, mILOA modified Iowa Level of Activity, PFIT-s Physical Function ICU Test-Scored, SGA Subjective Global Assessment
Back to article page

Pilot and Feasibility Studies

ISSN: 2055-5784