ICU-acquired Weakness, Muscle Weakness
Conditions
Keywords
ICU-acquired weakness
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTHMB protein supplement (3g)
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.
DIETARY_SUPPLEMENTNutritional Supplement
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
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients age ≥65 years. 2. Acute respiratory failure (ARF, defined by expected mechanical ventilation for \> 72 hours from the point of screening) 3. Elevated nutritional risk (NUTRIC score\>5 - see below).
Exclusion criteria
1. Over 72 hours from ICU admission. 2. Not expected to survive another 48 hours 3. Lack of commitment to full, aggressive care 4. Patients who have an absolute contraindication to EN (obstruction, perforation, high output fistula), 5. Pregnant women 6. Prisoners 7. Known allergy to study nutrients 8. Unable to walk prior to current illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walk distance | At 42 days follow up | Maximum distance walked by subject in 6 minutes on level ground |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition-Calf circumference | At 42 days follow up | Measurement of the calf circumference |
| Body Composition-Quadriceps layer muscle thickness (QLMT) | At 42 days follow up | Thigh ultrasound for quadriceps muscle thickness |
| Hand-grip strength (HGS) | At 42 days follow up | Measurement of force of isometric grip strength using hand-held dynamometer |
| Timed Get Up and Go test | At 42 days follow up | Time for subject to go from sitting to standing unaided |
Countries
United States
Outcome results
None listed