Improving Muscle Function in Nutritionally at Risk, Elderly Patients

Muscle Weakness Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03071354
• Other study ID #: IRB00035962
• Status: Withdrawn
• Phase: N/A
• First received: February 28, 2017
• Last updated: February 1, 2018
• Start date: May 1, 2017
• Est. completion date: May 22, 2017

Study information

• Verified date: August 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ICU-acquired Weakness
• Muscle Weakness
• Paresis

Intervention

Dietary Supplement:
• HMB 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.
• Nutritional 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

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk distance	Maximum distance walked by subject in 6 minutes on level ground	At 42 days follow up
Secondary	Body Composition-Calf circumference	Measurement of the calf circumference	At 42 days follow up
Secondary	Body Composition-Quadriceps layer muscle thickness (QLMT)	Thigh ultrasound for quadriceps muscle thickness	At 42 days follow up
Secondary	Hand-grip strength (HGS)	Measurement of force of isometric grip strength using hand-held dynamometer	At 42 days follow up
Secondary	Timed Get Up and Go test	Time for subject to go from sitting to standing unaided	At 42 days follow up