None listed
Conditions
Brief summary
Patients who survive ICU stay often develop important muscle weakness and rapid reduction in muscle mass. Furthermore, they often have notable deficits in nutritional intake. These changes in body composition and nutritional shortfalls may negatively impact long term outcomes and recovery. Therefore, ward based interventions or therapeutic agents which may slow muscle loss or aid in recovery from critical illness associated muscle loss have the potential to deliver clinical benefits. This study aims to determine the feasibility of providing a nutrition intervention to critically ill multi-trauma populations throughout hospital admission at the Royal Melbourne Hospital. Secondly, we aim to describe nutrition related patient outcomes (including anthropometric changes, nutritional intake, muscle strength and physical function) in this group.
Interventions
Intervention: 3 grams of Calcium ß-Hydroxy-ß-Methylbutrate (HMB-Ca) dissolved in either 150ml of orange juice for those allowed oral intake or 150ml of water for those being enterally fed.
The intervention/ control will be administered by a nurse once daily over hospital admission from day 1 post enrollment until day 28 or hospital discharge. Consumption of the intervention/placebo will be monitored daily through nursing administration records in the medication administration records.
In a s
Intervention: 3 grams of Calcium ß-Hydroxy-ß-Methylbutrate (HMB-Ca) dissolved in either 150ml of orange juice for those allowed oral intake or 150ml of water for those being enterally fed. The intervention/ control will be administered by a nurse once daily over hospital admission from day 1 post enrollment until day 28 or hospital discharge. Consumption of the intervention/placebo will be monitored daily through nursing administration records in the medication administration records. In a sub-group of patients who do not meet additional exclusion criteria and whose medical treatment decision maker (MTDM) provide consent, a muscle biopsy and plasma sample will be collected on day 1 post enrollment and again at day 7 post enrollment.
Sponsors
The Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a. Adults, 18 years of age and older b. Completed two full calendar days in ICU c. The predominant reason for ICU admission was a traumatic injury d. Allowed enteral/ oral nutrition at the time of randomization Inclusion criteria for the muscle biopsy sub group as above.
Exclusion criteria
a. Death during ICU admission deemed to be inevitable b. Bilateral above knee amputation c. Patients assessed as requiring completely or predominantly parenteral nutrition d. Pregnancy e. Primary neuromuscular pathology present or strongly suspected this admission episode f. Presumed transection of the spinal cord at any level g. Medical decision treatment maker, participant or medical practitioner declined consent h. Limited research availability over enrolment timeframe I. Enrollment conflict with other research studies j. Unlikely to be able to participate in long term follow up measures k. Unable to obtain consent within 7 days from initial traumatic injury Additional exclusion criteria for the muscle biopsy sub-group: g. Not mechanically ventilated at the time of enrollment or predicted to be extubated within 48 hours of enrollment. h. Present or strongly suspected disseminated cancer of any kind i. Bleeding diathesis (corrected INR > 1.5 and/or APTT > 50 sec), or receiving any anticoagulant medication beyond that required for venous thromboembolism prophylaxis, or any antiplatelet drug other than low dose aspirin
Outcome results
None listed