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

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ClinicalTrials.gov Identifier: NCT03193632
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Eslam Ayman Mohamed Shawki, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment
Resting Energy Expenditure Diagnostic Test: US Muscle layer thickness (MLT) estimation Diagnostic Test: REE estimation by indirect calorimetry

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.


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

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): NCT03193632


Locations
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Egypt
Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)
Cairo, Egypt
Sponsors and Collaborators
Eslam Ayman Mohamed Shawki

Publications:

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Responsible Party: Eslam Ayman Mohamed Shawki, Lecturer of anesthesia, SICU & Pain Management, Cairo University
ClinicalTrials.gov Identifier: NCT03193632     History of Changes
Other Study ID Numbers: LBM_REE
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Eslam Ayman Mohamed Shawki, Cairo University:
lean body mass
resting energy expenditure
oxygen consumption
Indirect calorimetry
carbon dioxide excretion
respiratory quotient

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes