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

Resting Energy Expenditure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193632
• Other study ID #: LBM_REE
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Resting Energy Expenditure

Intervention

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. Thigh: MLT of the quadriceps femoris muscle (M. Vastus intermedius and M. rectus femoris) will be assessed bilaterally 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 Forearm: A point midway between the antecubital skin crease and the ulnar styloid was marked and muscle thickness down to the interosseus membrane
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Eslam Ayman Mohamed Shawki

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

Campbell IT, Watt T, Withers D, England R, Sukumar S, Keegan MA, Faragher B, Martin DF. Muscle thickness, measured with ultrasound, may be an indicator of lean tissue wasting in multiple organ failure in the presence of edema. Am J Clin Nutr. 1995 Sep;62(3):533-9. — View Citation

Covelli HD, Black JW, Olsen MS, Beekman JF. Respiratory failure precipitated by high carbohydrate loads. Ann Intern Med. 1981 Nov;95(5):579-81. — View Citation

Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. — View Citation

Fung EB. Estimating energy expenditure in critically ill adults and children. AACN Clin Issues. 2000 Nov;11(4):480-97. Review. — View Citation

Muller MJ, Illner K, Bosy-Westphal A, Brinkmann G, Heller M. Regional lean body mass and resting energy expenditure in non-obese adults. Eur J Nutr. 2001 Jun;40(3):93-7. — View Citation

Pineau JC, Guihard-Costa AM, Bocquet M. Validation of ultrasound techniques applied to body fat measurement. A comparison between ultrasound techniques, air displacement plethysmography and bioelectrical impedance vs. dual-energy X-ray absorptiometry. Ann Nutr Metab. 2007;51(5):421-7. Epub 2007 Nov 20. — View Citation

Rubinson L, Diette GB, Song X, Brower RG, Krishnan JA. Low caloric intake is associated with nosocomial bloodstream infections in patients in the medical intensive care unit. Crit Care Med. 2004 Feb;32(2):350-7. — View Citation

Sanada K, Kearns CF, Midorikawa T, Abe T. Prediction and validation of total and regional skeletal muscle mass by ultrasound in Japanese adults. Eur J Appl Physiol. 2006 Jan;96(1):24-31. Epub 2005 Oct 19. — View Citation

Walker RN, Heuberger RA. Predictive equations for energy needs for the critically ill. Respir Care. 2009 Apr;54(4):509-21. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between LBM derived from ultrasound MLT and REE by indirect calorimetry	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	Predictive equation for REE based on US measurement of MLT	generation of predictive equation of REE based on ultrasound measurement of MLT	24 hours of ICU admission
Secondary	Estimation of the effect of severity scores on the REE	Estimation of the effect of severity scores on the REE	24 hours of ICU admission