Improving Muscle Function in Nutritionally at Risk, Elderly Patients

NCT03071354 | Withdrawn

• 1 other identifier: IRB00035962
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness; ICU-acquired Weakness

Keywords

ICU-acquired weakness

Outcome Measures

Primary Outcomes (1)

• 6 minute walk distance

  Maximum distance walked by subject in 6 minutes on level ground

  At 42 days follow up

Secondary Outcomes (4)

• Body Composition-Calf circumference

  At 42 days follow up

• Body Composition-Quadriceps layer muscle thickness (QLMT)

  At 42 days follow up

• Hand-grip strength (HGS)

  At 42 days follow up

• Timed Get Up and Go test

  At 42 days follow up

Study Arms (2)

HMB Protein Supplementation Group

EXPERIMENTAL

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)

Control Group

ACTIVE COMPARATOR

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

Interventions

HMB protein supplement (3g) DIETARY_SUPPLEMENT

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.

Also known as: Ensure Active™ Muscle Health

HMB Protein Supplementation Group

Nutritional Supplement DIETARY_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

Also known as: Ensure® Original

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients age ≥65 years.
• Acute respiratory failure (ARF, defined by expected mechanical ventilation for \> 72 hours from the point of screening)
• Elevated nutritional risk (NUTRIC score\>5 - see below).

You may not qualify if:

• Over 72 hours from ICU admission.
• Not expected to survive another 48 hours
• Lack of commitment to full, aggressive care
• Patients who have an absolute contraindication to EN (obstruction, perforation, high output fistula),
• Pregnant women
• Prisoners
• Known allergy to study nutrients
• Unable to walk prior to current illness.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27105, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ravi Agarwala, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 6, 2017
• Study Start: May 1, 2017
• Primary Completion: May 22, 2017
• Study Completion: May 22, 2017
• Last Updated: February 5, 2018

Record last verified: 2017-08

Locations

US (1)