Improving Muscle Function in Nutritionally at Risk, Elderly Patients

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Muscle Weakness; ICU-acquired Weakness

Treatments: Dietary Supplement: HMB protein supplement (3g); Dietary Supplement: Nutritional Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03071354

IRB00035962

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

HMB Protein Supplementation Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: HMB protein supplement (3g)

Control Group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nutritional Supplement