Improving Muscle Function in Nutritionally at Risk, Elderly Patients

Study Overview
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Brief Summary
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The investigators propose to conduct a randomized, control trial of β-hydroxy-β-methylbutyrate (HMB) supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily until day 28 following randomization (even if discharged).The investigators will measure functional outcomes using standard, validated measures prior and after discharge.

Detailed Description
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The investigators propose to conduct a randomized, control trial of HMB supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily until day 28 following randomization (even if discharged).the investigators will measure functional outcomes using standard, validated measures prior and after discharge. The investigators hypothesize that this inexpensive nutrient, HMB, along with our supportive measures, reduces muscle loss, improves physical muscle function, and improves quality of life in the longer term following critical illness.

Official Title
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Phase II, Multi-center, Randomized Control Trial of Beta- Hydroxy-Methyl-Butyrate (HMB) in Improving Physical Muscle Function, in Nutritionally at Risk, Elderly Patients

Conditions
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Muscle Weakness, ICU-acquired Weakness

Intervention / Treatment
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* Dietary Supplement: HMB protein supplement (3g)
* Dietary Supplement: Nutritional Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age ≥65 years. Acute respiratory failure (ARF, defined by expected mechanical ventilation for > 72 hours from the point of screening) Elevated nutritional risk (NUTRIC score>5 - see below). Exclusion Criteria: Over 72 hours from ICU admission. Not expected to survive another 48 hours Lack of commitment to full, aggressive care Patients who have an absolute contraindication to EN (obstruction, perforation, high output fistula), Pregnant women Prisoners Known allergy to study nutrients Unable to walk prior to current illness.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HMB Protein Supplementation Group<br>Intervention patients will receive 2 x 237mL bottles of the commercially available liquid HMB protein supplement (3g) (Ensure Active™ Muscle Health) throughout the study. In addition, all patients will be fed according to the Canadian Critical Nutrition Practice Guidelines, and protein/energy requirements will be determined by the local dietitians according to their local practice standards. | Dietary Supplement: HMB protein supplement (3g)<br>* HMB 3g/day or iso-nitrogenous control (discussed below) in addition to standard enteral, and parenteral nutritional supplementation and standard nutrition when transferred to the ward. The dose of HMB was chosen based on multiple studies revealing efficacy of 3g/day improving muscle mass and demonstrating an excellent safety profile. Feeding will be initiated as per local practice. Enrolled patients will be randomized to supplementation with HMB (3g) or control will begin within 72 hours of admission to ICU.<br>* Other names: Ensure Active™ Muscle Health;|
| Active Comparator: Control Group<br>Control patients will receive 2 x 237mL bottles of the commercially available nutritional supplement (Ensure® Original) throughout the study. In addition, all patients will be fed according to the Canadian Critical Nutrition Practice Guidelines, and protein/energy requirements will be determined by the local dietitians according to their local practice standards. | Dietary Supplement: Nutritional Supplement<br>* Control patients will receive 2 x 237mL bottles of the commercially available nutritional supplement (Ensure® Original) in addition to standard enteral, and parenteral nutritional supplementation and standard nutrition when transferred to the ward throughout the study. While the patient is intubated, the control nutritional supplement will be delivered via the enteral feeding tube. The participant will switch to oral administration once extubated<br>* Other names: Ensure® Original;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk distance | Maximum distance walked by subject in 6 minutes on level ground | At 42 days follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition-Calf circumference | Measurement of the calf circumference | At 42 days follow up | 
| Body Composition-Quadriceps layer muscle thickness (QLMT) | Thigh ultrasound for quadriceps muscle thickness | At 42 days follow up | 
| Hand-grip strength (HGS) | Measurement of force of isometric grip strength using hand-held dynamometer | At 42 days follow up | 
| Timed Get Up and Go test | Time for subject to go from sitting to standing unaided | At 42 days follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU-acquired weakness