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

August 20, 2020 updated by: Mette M Berger

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1011
        • University of Lausanne Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HMB (beta-hydroxy beta-methylbutyrate)
HMB, 1.5 g b.i.d., from day 4 to day 30 after ICU admission
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)
Placebo Comparator: Placebo
Maltodextrin, 1.5 g b.i.d., from day 4 to day 30 after ICU admission
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change between Day 4 and Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change between Day 4 and Day 15
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))
Change between Day 4 and Day 15
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
Measurements on Days 4, 15, and 30
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
on days 30 and 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mette M Berger

Collaborators

Texas A&M University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2018

Primary Completion (Actual)

January 6, 2020

Study Completion (Actual)

January 6, 2020

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-2018-00556

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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