Improving Muscle Function in Nutritionally at Risk, Elderly Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Muscle Weakness; ICU-acquired Weakness
• Intervention / Treatment: Dietary supplement: HMB protein supplement (3g); Dietary supplement: Nutritional Supplement

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27105
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HMB Protein Supplementation Group; 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.	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.; Other Names: Ensure Active™ Muscle Health
ACTIVE_COMPARATOR: Control Group; 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.	Dietary supplement: 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; Other Names: Ensure® Original

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk distance	Maximum distance walked by subject in 6 minutes on level ground	At 42 days follow up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Ravi Agarwala, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): May 22, 2017
• Study Completion (ACTUAL): May 22, 2017

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (ACTUAL): March 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: ICU-acquired weakness
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Asthenia
• Other Study ID Numbers: IRB00035962

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No