Skip to main content
OpenTrials
Completed

NCT Number: NCT03628365

Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients?

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Illness Disease Attributes Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lausanne Hospitals

Lausanne, 1011, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HMB (beta-hydroxy beta-methylbutyrate)

Dietary Supplement

1.5 g, b.i.d., by the enteral route, from Day 4 to Day 30 (minimum 10 days)

Primary outcomes

  1. Muscle mass of the thigh

    Time frame: Change between Day 4 and Day 15

    Ultrasound cross sectional area of the thigh, to quantify muscle loss

Secondary outcomes

  1. Body composition

    Time frame: Change between Day 4 and Day 15

    Bioelectrical impedance analysis (BIA): calculation of body compartments, lean body mass, and phase angle

  2. Protein synthesis and breakdown

    Time frame: 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))

  3. Muscle strength (global and handgrip)

    Time frame: 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

  4. Global Health and Mobility

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mette M Berger

Other

Collaborators

  • Texas A&M University

Registry information

Official study title

Can Beta-Hydroxy-beta-Methylbutyrate (HMB) Supplementation Counteract Muscle Catabolism in Critically Ill Patients? A Randomized Controlled Trial

Acronym: HMB-ICU-CH

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2018
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.