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

NCT04303650 | Completed DMC

• 1 other identifier: 5968-5-3-2020
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

• correlation between Nitrogen Balance and quadriceps muscle layer thickness (QMLT)

  To determine the correlation between Nitrogen Balance and QMLT detected by ultrasound

  10 days

Secondary Outcomes (2)

• relationship between QMLT, pre-albumin, and CRP

  10 days

• The impact of QMLT and NB on 28 day mortality.

  28 day

Interventions

Ultrasound measurement of quadriceps muscle layer thickness DEVICE

With patient in supine position ultrasound will be performed using a 12MHZ Transducer connected to Sonosite M Turbo machine. The probe will be placed perpendicular to the long axis of the thigh on its anterior surface at the two thirds of the length between the anterior superior iliac spine and the upper border of the patella. After identifying the muscle tissue, the thickness of the quadriceps muscle will be obtained by measuring the distance between the cortex of femur and the most superficial muscular fascia. Measurements will be performed by applying maximal compression on the probe without inflicting pain to prevent underestimation of muscle wasting linked to subcutaneous edema. measurements will be made on both sides repeatedly on ICU days 1, 3, 7, and 10. Every time three ultrasound measurements will be taken per site and the average of three measurements for each site will be used and combined to provide total muscle depth

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Emergency and Surgical Intensive Care Units, Zagazig University Hospitals

Zagazig, Sharqia Province, 44111, Egypt

Location

Related Publications (12)

• Liebau F, Wernerman J, van Loon LJ, Rooyackers O. Effect of initiating enteral protein feeding on whole-body protein turnover in critically ill patients. Am J Clin Nutr. 2015 Mar;101(3):549-57. doi: 10.3945/ajcn.114.091934. Epub 2015 Feb 4.

  PMID: 25733640 BACKGROUND

• Fock RA, Blatt SL, Beutler B, Pereira J, Tsujita M, de Barros FE, Borelli P. Study of lymphocyte subpopulations in bone marrow in a model of protein-energy malnutrition. Nutrition. 2010 Oct;26(10):1021-8. doi: 10.1016/j.nut.2009.08.026. Epub 2009 Dec 29.

  PMID: 20036516 BACKGROUND

• Rai J, Gill SS, Kumar BR. The influence of preoperative nutritional status in wound healing after replacement arthroplasty. Orthopedics. 2002 Apr;25(4):417-21. doi: 10.3928/0147-7447-20020401-17.

  PMID: 12002213 BACKGROUND

• Latronico N, Herridge M, Hopkins RO, Angus D, Hart N, Hermans G, Iwashyna T, Arabi Y, Citerio G, Ely EW, Hall J, Mehta S, Puntillo K, Van den Hoeven J, Wunsch H, Cook D, Dos Santos C, Rubenfeld G, Vincent JL, Van den Berghe G, Azoulay E, Needham DM. The ICM research agenda on intensive care unit-acquired weakness. Intensive Care Med. 2017 Sep;43(9):1270-1281. doi: 10.1007/s00134-017-4757-5. Epub 2017 Mar 13.

  PMID: 28289812 BACKGROUND

• Andonovska, B.J., Andonovski, A.G., Kuzmanovska, B., Kartalov, A., Temelkovski, Z. the influence of nutrition on muscle wasting in critically ill patients - a pilot study.Sanamed 2018; 13(3):235 - 41

  BACKGROUND

• Felicetti-Lordani CR, Eckert RG, Valerio NMP,et al. Nitrogen balance in nutritional monitoring of critically ill adult patients:A prospective observational study.Yoğun Bakım Derg 2018; 8: 59-64.

  BACKGROUND

• Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 BACKGROUND

• Nakanishi N, Oto J, Tsutsumi R, Iuchi M, Onodera M, Nishimura M. Upper and lower limb muscle atrophy in critically ill patients: an observational ultrasonography study. Intensive Care Med. 2018 Feb;44(2):263-264. doi: 10.1007/s00134-017-4975-x. Epub 2017 Nov 6. No abstract available.

  PMID: 29110031 BACKGROUND

• Price KL, Earthman CP. Update on body composition tools in clinical settings: computed tomography, ultrasound, and bioimpedance applications for assessment and monitoring. Eur J Clin Nutr. 2019 Feb;73(2):187-193. doi: 10.1038/s41430-018-0360-2. Epub 2018 Oct 30.

  PMID: 30377307 BACKGROUND

• Weinel LM, Summers MJ, Chapple LA. Ultrasonography to measure quadriceps muscle in critically ill patients: A literature review of reported methodologies. Anaesth Intensive Care. 2019 Sep;47(5):423-434. doi: 10.1177/0310057X19875152. Epub 2019 Oct 22. No abstract available.

  PMID: 31640395 BACKGROUND

• McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available.

  PMID: 26773077 BACKGROUND

• Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.

  PMID: 30348463 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Fatma M Ahmed, MD

  Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University

  STUDY DIRECTOR

• Sherif MS Mowafy, MD

  Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 11, 2020
• Study Start: March 15, 2020
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: the IPD and any additional supporting information will become available starting 6 months after publication.
• Access Criteria: by contacting the study director

Locations

EG (1)