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Improving Muscle Function in Nutritionally at Risk, Elderly Patients

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ClinicalTrials.gov Identifier: NCT03071354
Recruitment Status : Withdrawn (Principal Investigator is Moving Institutions)
First Posted : March 6, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Muscle Weakness ICU-acquired Weakness Dietary Supplement: HMB protein supplement (3g) Dietary Supplement: Nutritional Supplement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : May 22, 2017
Actual Study Completion Date : May 22, 2017

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 Name: 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 Name: Ensure® Original




Primary Outcome Measures :
  1. 6 minute walk distance [ Time Frame: At 42 days follow up ]
    Maximum distance walked by subject in 6 minutes on level ground


Secondary Outcome Measures :
  1. Body Composition-Calf circumference [ Time Frame: At 42 days follow up ]
    Measurement of the calf circumference

  2. Body Composition-Quadriceps layer muscle thickness (QLMT) [ Time Frame: At 42 days follow up ]
    Thigh ultrasound for quadriceps muscle thickness

  3. Hand-grip strength (HGS) [ Time Frame: At 42 days follow up ]
    Measurement of force of isometric grip strength using hand-held dynamometer

  4. Timed Get Up and Go test [ Time Frame: At 42 days follow up ]
    Time for subject to go from sitting to standing unaided



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071354


Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27105
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Ravi Agarwala, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03071354    
Other Study ID Numbers: IRB00035962
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Wake Forest University Health Sciences:
ICU-acquired weakness
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes