Critical Illness, Muscle Weakness
Conditions
Keywords
Body composition, muscle mass, protein metabolism, enteral nutrition, ICU
Brief summary
The rapid decline of muscle mass and function in mechanically ventilated critically ill patients is associated with prolonged length of mechanical ventilation, prolonged intensive care (ICU) and hospital stay, increased ICU and hospital mortality, and prolonged impairment in physical function and quality of life. High protein feeding only partially attenuates the muscle loss. The aim is to study the impact of HMB (3 g/day) on the muscle mass of the critically ill patients from day 4 of their admission to maximum 30 days, but at least for 10 days.
Detailed description
The rapid decline of muscle mass and function in mechanically ventilated critically ill patients is associated with poor outcome, and limitations of functional recovery. High protein feeding only partially attenuates the muscle loss. The aim is to study the impact of HMB (3 g/day) on the muscle mass of the critically ill patients from day 4 of their admission to maximum 30 days, but at least for 10 days. The study is testing a nutrition complement (HMB) that is included in feeding products registered for medical nutrition by Swiss Federal Authorities, but who do not provide sufficient protein quantities. On days 4 and 15 after ICU admission, specific investigations will include: Ultrasound measurement of the muscle quadriceps femoris (CSA), bioimpedance analysis (BIA) of body composition, protein synthesis and catabolism using amino acid tracers. On D30 and D60: telephone contact to assess global health and mobility (SF-12).
Interventions
DIETARY_SUPPLEMENTHMB (beta-hydroxy beta-methylbutyrate)
1.5 g, b.i.d., by the enteral route, from Day 4 to Day 30 (minimum 10 days)
Sponsors
Texas A&M University
Mette M Berger
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomisation controlled by the Hospital Pharmacy Intervention product masked by the Hospital Pharmacy
Intervention model description
Randomised, double blind, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* likely length of stay \>5 days * on mechanical ventilation * likely survival \>7 days * full treatment * functional gastro-intestinal tract * presence of a central venous catheter
Exclusion criteria
* absence of consent * less than 18 years patients * gastro-intestinal dysfunction * major burns \>20% body surface * admission for cardio-respiratory arrest or brain injury * pregnancy or lactation * diabetes mellitus (I and II) * statin treatment * patient on parenteral nutrition * absence of central venous line * participation in another interventional trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass of the thigh | Change between Day 4 and Day 15 | Ultrasound cross sectional area of the thigh, to quantify muscle loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | Change between Day 4 and Day 15 | Bioelectrical impedance analysis (BIA): calculation of body compartments, lean body mass, and phase angle |
| Protein synthesis and breakdown | Change between Day 4 and Day 15 | Multiple Amino acid tracer study: to detect chnges in protein metabolism between study start on day 4 and day 14 (i.e. after 10 days of intervention (HMB or placebo)) |
| Muscle strength (global and handgrip) | Measurements on Days 4, 15, and 30 | Medical Research Council muscle score (MRC) to assess upper and lower limb strength, and handgrip strength (not always feasible in ICU patients) and determine magnitude of strength loss |
| Global Health and Mobility | on days 30 and 60 | Short Form 12 (SF-12) questionnaire to assess global health and mobility: range 12 to 56 points, the upper limit reflecting return to normal activity |
Countries
Switzerland
Outcome results
None listed