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

Critical Illness Clinical Trial

— HMB-ICU-CH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628365
• Other study ID #: CER-2018-00556
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: January 6, 2020

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Muscle Weakness

Intervention

Dietary Supplement:
• HMB (beta-hydroxy beta-methylbutyrate)
1.5 g, b.i.d., by the enteral route, from Day 4 to Day 30 (minimum 10 days)

Locations

Country	Name	City	State
Switzerland	University of Lausanne Hospitals	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Mette M Berger	Texas A&M University

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Deutz NE, Matheson EM, Matarese LE, Luo M, Baggs GE, Nelson JL, Hegazi RA, Tappenden KA, Ziegler TR; NOURISH Study Group. Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A rando — View Citation

Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of ß-hydroxy-ß-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 M — View Citation

Engelen MPKJ, Deutz NEP. Is ß-hydroxy ß-methylbutyrate an effective anabolic agent to improve outcome in older diseased populations? Curr Opin Clin Nutr Metab Care. 2018 May;21(3):207-213. doi: 10.1097/MCO.0000000000000459. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass of the thigh	Ultrasound cross sectional area of the thigh, to quantify muscle loss	Change between Day 4 and Day 15
Secondary	Body composition	Bioelectrical impedance analysis (BIA): calculation of body compartments, lean body mass, and phase angle	Change between Day 4 and Day 15
Secondary	Protein synthesis and breakdown	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))	Change between Day 4 and Day 15
Secondary	Muscle strength (global and handgrip)	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	Measurements on Days 4, 15, and 30
Secondary	Global Health and Mobility	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	on days 30 and 60