Improving Muscle Function in Nutritionally at Risk, Elderly Patients

Not Applicable

Withdrawn

• Conditions: ICU-acquired Weakness; Muscle Weakness
• Interventions: Dietary Supplement: Nutritional Supplement; Dietary Supplement: HMB protein supplement (3g)

• Registration Number: NCT03071354
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-06
• Study Start: 2017-05-01
• Primary Completion: 2017-05-22
• Study Completion: 2017-05-22
• Status Verified: 2017-08
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Nutritional Supplement	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.
HMB Protein Supplementation Group	HMB protein supplement (3g)	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.

Primary Outcome Measures

Name	Time	Method
6 minute walk distance	At 42 days follow up	Maximum distance walked by subject in 6 minutes on level ground

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States