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Improving Muscle Function in Nutritionally at Risk, Elderly Patients

NCT03071354 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-02-05

No results posted yet for this study

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

Interventions

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.

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

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Ravi Agarwala, MD · Wake Forest University Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2017-05-22
Completion
2017-05-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03071354 on ClinicalTrials.gov