The Relation Between Quadriceps Muscle Layer Thickness and Nitrogen Balance for Nutrition Monitoring

December 4, 2023 updated by: Sherif M. S. Mowafy, Zagazig University

The Relation Between Sonographic Quadriceps Muscle Layer Thickness and Nitrogen Balance for Nutrition Monitoring in Adult Critically Ill Trauma Patients

Loss of muscle mass is a major cause of intensive care unit-acquired weakness (ICU-AW) and is associated with delayed weaning; prolonged ICU and hospital stay and is an independent predictor of one year mortality.

Theoretically, the best strategy to minimize muscle loss during ICU stay, is delivering an appropriate nutritional support. Studying the correlation between the sequential assessments of quadriceps femoris muscle layer thickness (QMLT) by the aid of Ultrasound in addition to the traditional method (NB) for assessment of nutritional status may be helpful to predict outcome and mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Protein catabolism and proteolysis, mainly in the skeletal muscles is highly accelerated in critical illness with severe acute inflammatory processes, such as sepsis, burns, and polytrauma patients. The resulting catabolic state may be linked to immunosuppression, poor wound healing, and intensive care unit-acquired weakness (ICU-AW), which are associated with delayed recovery and increased mortality. In order to prevent muscle-protein depletion, several strategies have been proposed. One of them is adequate nutrition. Higher protein intake appears to be beneficial and could mitigate the negative catabolic state by increasing the availability of exogenous amino acids.

The adequacy of protein intake could only be optimized by appropriate monitoring. Nitrogen balance (NB) is the commonly used tool in this context. It is considered a good marker of adequate protein intake, easy, and available method of assessing the success of nutritional therapy as it reflects the gain or loss of total body proteins by calculating the difference between dietary nitrogen intake and nitrogen losses.

Moreover, a considerable reduction in muscle mass begins within the first 3 days of ICU admission and progressively worsens; therefore quantifying the muscle size may help in recognizing patients at risk of ICU acquired weakness and also may guide the interventions to prevent this complication. So, it may help in monitoring the adequacy of nutritional therapy and protein intake.

The primary methods that have been explored to measure musculature include computed tomography (C.T), magnetic resonance imagining (MRI), ultrasonography (US), and bioimpedance. Ultrasonography as a noninvasive, practical, readily available, and bedside technique could be considered the first option for the quantification of muscle size in these patients.

The quadriceps muscle is the most studied muscle found to have strong correlation with muscle mass and strength. Its size can be measured by either the quadriceps muscle layer thickness (QMLT) or the cross-sectional area (CSA). However, QMLT have greater practicability as measurements could be obtained rapidly and in real time as well as it easier to identify than CSA.

Since, monitoring is the key to individualize and optimize the critical protein intake. We hypothesized that QMLT evaluation by ultrasound could be used to guide nutritional protein intake and is correlated to conventional monitoring with nitrogen balance in critically ill trauma patients.

Study Type

Observational

Enrollment (Actual)

186

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
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44111
        • Emergency and Surgical Intensive Care Units, Zagazig University Hospitals

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Critically ill trauma patients aged between 18 - 60 years of both sexes

Description

Inclusion Criteria:

  • Anticipated to be mechanically ventilated to >48hour and expected to Stay in ICU > 4 days.
  • No contraindication to early enteral nutrition.
  • Enteral feeding in the first 24 hours after admission, with a minimum protein contribution of 1 gm / kg / day.
  • We recruited only well nourished, previously healthy patients with no past history of nutritional problems.

Exclusion Criteria:

  • Patients with preexisting neuromuscular pathology, lower limb amputation, skeletal fractures or immobilization in the previous 2years.
  • Patients with relevant Co-morbidities (renal, liver or heart disease or COPD), previous immune abnormalities including those receiving corticosteroids, and those with past or recent history of cancer.
  • Patients with anuria owing to the difficulty in evaluating excreted urea nitrogen
  • Whose ultrasound data will be missing or incomplete
  • Pregnancy
  • Patients who will not reach the goal in enteral protein intake for any reason (gastrointestinal intolerance, contraindication to enteral feeding or repeated interruptions of enteral feeding due to multiple surgical procedures) or those who start 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between Nitrogen Balance and quadriceps muscle layer thickness (QMLT)
Time Frame: 10 days
To determine the correlation between Nitrogen Balance and QMLT detected by ultrasound
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relationship between QMLT, pre-albumin, and CRP
Time Frame: 10 days
To determine the correlation between pre-albumin and CRP and QMLT detected by ultrasound
10 days
The impact of QMLT and NB on 28 day mortality.
Time Frame: 28 day
To determine the correlation between nitrogen balance and QMLT detected by ultrasound and the outcome by 28 day mortality.
28 day

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Study Director: Fatma M Ahmed, MD, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
  • Principal Investigator: Sherif MS Mowafy, MD, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University

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)

March 15, 2020

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

March 8, 2020

First Submitted That Met QC Criteria

March 8, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5968-5-3-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in the publication

IPD Sharing Time Frame

the IPD and any additional supporting information will become available starting 6 months after publication.

IPD Sharing Access Criteria

by contacting the study director

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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