Improving Muscle Function in Nutritionally at Risk, Elderly Patients



Status:Withdrawn
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:65 - Any
Updated:2/7/2018
Start Date:May 1, 2017
End Date:May 22, 2017

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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

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.

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.

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.
We found this trial at
1
site
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
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