NCT03193632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

June 19, 2017

Last Update Submit

October 2, 2018

Conditions

Keywords

lean body massresting energy expenditureoxygen consumptionIndirect calorimetrycarbon dioxide excretionrespiratory quotient

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Predictive equation for REE based on US measurement of MLT

    24 hours of ICU admission

  • Estimation of the effect of severity scores on the REE

    24 hours of ICU admission

Study Arms (1)

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) estimationDiagnostic Test: REE estimation by indirect calorimetry

Interventions

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

Study group

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.

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • \- Patient requiring ventilatory support \> 24 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Egypt

Location

Related Publications (9)

  • 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. doi: 10.1097/01.CCM.0000089641.06306.68.

    PMID: 14758147BACKGROUND
  • Covelli HD, Black JW, Olsen MS, Beekman JF. Respiratory failure precipitated by high carbohydrate loads. Ann Intern Med. 1981 Nov;95(5):579-81. doi: 10.7326/0003-4819-95-5-579.

    PMID: 6794409BACKGROUND
  • Walker RN, Heuberger RA. Predictive equations for energy needs for the critically ill. Respir Care. 2009 Apr;54(4):509-21.

    PMID: 19327188BACKGROUND
  • Fung EB. Estimating energy expenditure in critically ill adults and children. AACN Clin Issues. 2000 Nov;11(4):480-97. doi: 10.1097/00044067-200011000-00002.

    PMID: 11288413BACKGROUND
  • 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. doi: 10.1093/ajcn/62.3.533.

    PMID: 7661114BACKGROUND
  • 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. doi: 10.1007/s00421-005-0061-0. Epub 2005 Oct 19.

    PMID: 16235068BACKGROUND
  • 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. doi: 10.1159/000111161. Epub 2007 Nov 20.

    PMID: 18025814BACKGROUND
  • 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. doi: 10.1001/jama.289.22.2983.

    PMID: 12799407BACKGROUND
  • 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. doi: 10.1007/s003940170008.

    PMID: 11697446BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of anesthesia, SICU & Pain Management

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 21, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

October 4, 2018

Record last verified: 2018-10

Locations