A Study to Investigate the Effect of ß-Hydroxy-ß-Methylbutyrate (HMB) on Skeletal Muscle Wasting in Early Critical Illness.

Phase 1

• Conditions: Critical illness; MedDRA version: 20.0Level: PTClassification code 10077264Term: Critical illnessSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2016-003557-15-GB
• Lead Sponsor: Guy's and St Thomas NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-25
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Inclusion criteria are
(i) =18 years old
(ii) Due to receive enteral nutrition via a nasogastric or naso-jejunal tube as part of routine care
(iii) Receiving mechanical ventilation and likely to continue this for more than 48 hours
(iv) Likely to remain on the ICU for >7 days
(v) Likely to survive intensive care admission.
(vi) Admitted to recruiting ICU <24 hours from hospital admission and referring ICU ? 7 days from hospital admission
(vii) Agreement obtained from legal representative
(viii) Able to comply with protocol and study procedures
(ix) No known allergy to IMP or any of its excipients
Participants in other trials can be recruited where protocols are not deemed likely to interfere with endpoints of either study and agreement has been obtained from the respective Chief Investigators.
Since participants in the trial will be abstaining by virtue of their illness, contraception is not required as an eligibility requirement.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

(i) Pregnancy or breast feeding
(ii) Active disseminated malignancy (diagnosed)
(iii) Bilateral lower limb amputees
(iv) Non-ambulant or acute unilateral lower limb amputees
(v) Patients with a primary neuromyopathy
(vi) Patients entered into trials of interventions which would affect muscle mass
(vii) Patients assessed as requiring sole parenteral nutrition
(viii) Admission to ICU within the previous 3 months
(ix) Any reason excluding ultrasound measurement being performed
(ix) Insufficient understanding of the trial by the legal representative
(xi) Intolerance to lactose and/or milk protein allergy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of HMB on skeletal muscle mass in early critical illness.;Secondary Objective: •To determine the effect of HMB on muscle quality, strength, function and quality of life in ICU survivors.<br>•To investigate the effect of HMB on inflammation, cell damage and plasma metabolomics profile over the first 10 days of ICU admission <br>•To investigate the effects of HMB on muscle necroptosis (e.g. through TNF-receptor activation) using a primary cell culture assay. <br>•To establish the feasibility of such an intervention with the view to designing a multicentre randomised controlled trial.<br>;Primary end point(s): Change in rectus femoris cross-sectional area (RFcsa) at day 10 following Intensive Care Unit (ICU) admission;Timepoint(s) of evaluation of this end point: Day 10