Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients? (HMB-ICU-CH)

Mette M Berger

Status: Completed

Conditions: Critical Illness; Muscle Weakness

Treatments: Dietary Supplement: HMB (beta-hydroxy beta-methylbutyrate)

Study type: Interventional

Funder types: Other

Identifiers

NCT03628365

CER-2018-00556

Details and patient eligibility

About

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.

Full 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).

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups, including a placebo group

HMB (beta-hydroxy beta-methylbutyrate)

Active Comparator group

Description:

HMB, 1.5 g b.i.d., from day 4 to day 30 after ICU admission

Treatment:

Dietary Supplement: HMB (beta-hydroxy beta-methylbutyrate)

Placebo

Placebo Comparator group

Description:

Maltodextrin, 1.5 g b.i.d., from day 4 to day 30 after ICU admission

Treatment:

Dietary Supplement: HMB (beta-hydroxy beta-methylbutyrate)