Predicting Resting Energy Expenditure in Critically Ill Patients by Measuring Lean Body Mass by US

October 2, 2018 updated by: Eslam Ayman Mohamed Shawki

The Novel Use of Point of Care Ultrasound to Predict Resting Energy Expenditure in Critically Ill Patients by Measuring Lean Body Mass Using Musculo-skeletal Ultrasound

The study aims to correlate Lean Body Mass (LBM) Evaluated by Musculoskeletal Ultrasound with Resting Energy Expenditure (REE) measured by Indirect Calorimetry and to generate a predictive equation of REE based on LBM, in addition to identifying other factors that may affect REE such as age, gender, and severity scores.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Caloric needs in critically-ill patients fluctuate significantly over the course of the disease which might expose patients to either malnutrition or overfeeding.Malnutrition is associated with deterioration of lean body mass (LBM), poor wound healing, increased risk of nosocomial infection, and weakened respiratory muscles. On the other hand overfeeding in medically compromised patients can promote lipogenesis, hyperglycemia, and exacerbation of respiratory failure. Many factors may affect the resting energy expenditure (REE) through manipulation of oxygen consumption (VO2). One of the strongest determinants of REE is the LBM.

A measurement of muscle mass and changes in muscle mass could thus provide an index of LBM in critically ill patients. At present, computerized tomography, magnetic resonance imaging and dual-energy X-ray absorptiometry (DXA) are widely used as reference methods for evaluating LBM in vivo. However, these methods are impractical in critically ill patients. More practically, ultrasound scanning is a simple, portable, safe, and a low-patient burden technique. Several studies found that the use of ultrasound can be a good estimate to LBM.

Indirect calorimetry remains the accepted standard for determining the REE in the critically ill. Indirect calorimetry measures oxygen consumption(VO2) and carbon dioxide excretion (VCO2 ) (both in mL/min), which are used to calculate the respiratory quotient and the resting energy expenditure. Although, the measured LBM has been shown as an important determinant of REE, there was no previous study tested the relationship between estimated LBM by ultrasound-based muscle thickness measurement and REE.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

critically-ill patients who will be admitted to the surgical ICU for ventilatory support and will be expected to continue more than one day

Description

Inclusion Criteria:

- Patient requiring ventilatory support > 24 hours

Exclusion Criteria:

  • Patient who will require FIO2 more than 0.6.
  • Air leak from the chest tube.
  • Patient with body temperature > 39oC.
  • Patients with known endocrine dysfunction.
  • Patients on parenteral nutrition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
critically-ill patients who will be admitted to the surgical ICU for ventilatory support and will be expected to continue for more than one day US Muscle layer thickness (MLT) estimation will be used to estimate LBM and REE estimation by indirect calorimetry will be performed
Diagnostic test: US Muscle layer thickness (MLT) estimation

Three measurements will be made at each of three sites; mid-upper arm, forearm and thigh anteriorly and the mean value will be calculated. Measurement sites will be marked with indelible ink to ensure day-to-day consistency.

  1. Thigh: MLT of the quadriceps femoris muscle (M. Vastus intermedius and M. rectus femoris) will be assessed bilaterally
  2. Mid-upper arm: Muscle layer thickness will be measured over the biceps,midway between the tip of the acromion and the tip of the olecranon
  3. Forearm: A point midway between the antecubital skin crease and the ulnar styloid was marked and muscle thickness down to the interosseus membrane
Diagnostic test: REE estimation by indirect calorimetry
REE will be calculated using indirect calorimetry via metabolic module on General Electric ventilator (Engstrom Carestation and Carescape R860, GE Health care, USA) All indirect calorimetric measurements will be done using standardized technique. Gas calibration will be performed before each measurement, and the measurements will last for at least 30 minutes. Measurements will be taken with the patient lying supine and ventilator settings left unchanged for at least 60 minutes ahead of indirect calorimetry. The REE will be calculated during the first 24 hours of admission to ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between LBM derived from ultrasound MLT and REE by indirect calorimetry
Time Frame: 24 hours of ICU admission
The correlation of the LBM derived from ultrasound MLT to the REE measured within 24 hours of ICU admission with indirect calorimetry
24 hours of ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive equation for REE based on US measurement of MLT
Time Frame: 24 hours of ICU admission
generation of predictive equation of REE based on ultrasound measurement of MLT
24 hours of ICU admission
Estimation of the effect of severity scores on the REE
Time Frame: 24 hours of ICU admission
Estimation of the effect of severity scores on the REE
24 hours of ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eslam Ayman Mohamed Shawki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBM_REE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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