Critical illness MedDRA version: 20.0 Level: PT Classification code 10077264 Term: Critical illness System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Product Name: ß-Hydroxy-ß-Methylbutyrate (HMB)
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE
Current Sponsor code: CALCIUM BETA-HYDROXY-BE
Sponsors
Guy's and St Thomas NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. • To investigate the effect of HMB on inflammation, cell damage and plasma metabolomics profile over the first 10 days of ICU admission • To investigate the effects of HMB on muscle necroptosis (e.g. through TNF-receptor activation) using a primary cell culture assay. • To establish the feasibility of such an intervention with the view to designing a multicentre randomised controlled trial. ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change in RFcsa at day 7, 10, ICU discharge, completion of the intervention, hospital discharge and 3 months post-hospital discharge. •Change in muscle echogenicity at 7, 10, ICU discharge, completion of the intervention, hospital discharge and 3 months post-hospital discharge. •Between and within group difference in strength change at ICU discharge, completion of the intervention, hospital discharge and 3 months post-hospital discharge. •Between and within group difference in physical function change at ICU discharge, completion of the intervention, hospital discharge and 3 months post-hospital discharge. •Difference in quality of life scores at 3 months post-hospital discharge. •Difference in inflammation, cell damage and plasma metabolic profile over the first 10 days of admission. ;Timepoint(s) of evaluation of this end point: Day 7, ICU discharge, hospital discharge and 3 months post-hospital discharge. Day 7, ICU discharge, hospital discharge and 3 months post-hospital discharge. Days 7, 10, ICU discharge, hospital discharge and 3-month post-hospital discharge. ICU discharge, hospital discharge and 3 months post-hospital discharge. ICU discharge, hospital discharge and 3 months post-hospital discharge. 3 months and 1-year post-hospital discharge. First 10 days of ICU admission | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Nicholas Hart
Guy's and St Thomas NHS Foundation Trust
Outcome results
None listed