Clinical trial NCT03071354: Improving Muscle Function in Nutritionally at Risk, Elderly Patients
Official title: Phase II, Multi-center, Randomized Control Trial of Beta- Hydroxy-Methyl-Butyrate (HMB) in Improving Physical Muscle Function, in Nutritionally at Risk, Elderly Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Muscle Weakness
ICU-acquired Weakness
Keywords: ICU-acquired weakness
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6 minute walk distance
timeFrame: At 42 days follow up
Secondary outcomes:
measure: Body Composition-Calf circumference
timeFrame: At 42 days follow up
measure: Body Composition-Quadriceps layer muscle thickness (QLMT)
timeFrame: At 42 days follow up
measure: Hand-grip strength (HGS)
timeFrame: At 42 days follow up
measure: Timed Get Up and Go test
timeFrame: At 42 days follow up
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ravi Agarwala, MD
role: PRINCIPAL_INVESTIGATOR
References: