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Atrophy of Rectus Femoris Muscle (Physical Finding)NCT06012201

Relationship Between Protein Intake and ICU Skeletal Muscle Weakness

An observational study of Atrophy of Rectus Femoris Muscle (Physical Finding), run by Tufts Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Muscle wasting is a common finding in critically ill patients and is associated with adverse outcomes. A good strategy for avoiding or decreasing muscle loss is adding adequate quantities of protein to the nutritional therapy administered during the acute phase of the disease during the ICU stay. Read more about this study

Who is it for?
Ages 18 to 50 years
How many people
60 participants
Where
No sites listed yet
Study dates
1 Sep 2023to Dec 2023
How long will I take part?
5 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: all mechanically ventilated patients with a Glasgow Coma Scale ≤ 8 within 24 hours after the injury. only well-nourished ( Modified Nutric -Score for Risk Screening = 0- 4), previously healthy subjects

Who may be able to join

  • Adult patients of both sexes, 18-50 years old with a Glasgow Coma Scale ≤ 8 and an injury severity score (ISS>15) were admitted to our ICU within 24 hours after the injury. only well-nourished ( Modified Nutric -Score for Risk Screening = 0- 4), previously healthy subjects will be recruited.

Who cannot join

  • Pregnancy, Patients with BMI ≥ 35,
  • Vascular insufficiency or trauma to the lower limbs,
  • History of neuromuscular diseases, Prolonged immobility prior to ICU admission,
  • Comorbidities (renal, hepatic, cardiac disorders, chronic obstructive pulmonary disease, and diabetic patient),
  • Patients with malignant diseases or immune disorders,
  • Prolonged corticosteroids (CS) or neuromuscular blocking agents (NMBA) use,
  • ARDS patient (P/F ratio ≤ 200), Sepsis, Multiorgan failure.

Trial locations and contacts

No sites are listed yet.

About this study

Muscle wasting is a common finding in critically ill patients and is associated with adverse outcomes. A good strategy for avoiding or decreasing muscle loss is adding adequate quantities of protein to the nutritional therapy administered during the acute phase of the disease during the ICU stay. The aim of this prospective study is to compare the effect of different levels of protein enteral feeding on Rectus Femoris Muscle mass in mechanically ventilated patients.

Read the detailed description

Muscle wasting is a common finding in critically ill patients and is associated with adverse outcomes. Loss of mass and function of skeletal muscles start early in the first 24 h after admission and may persist for years (post-ICU syndrome).

It is a major cause of ICU-acquired muscle weakness and is associated with delayed weaning, prolonged ICU and hospital stay, and is an independent predictor of 1-year mortality.

Long-term muscle impairment affects the quality of life of ICU survivors as it is responsible for physical, mental, and cognitive dysfunction and increases the costs of health care services.

Trauma is always associated with stress leading to multisystem alterations, changes in macronutrient metabolism, as well as endocrine-metabolic activities, and immunological responses.

The stress response increases energy expenditure (EE) and the use of protein reserves. The mobilization of these reserves is not a unidirectional catabolic process but it results in an imbalance between protein synthesis and degradation depending on the magnitude of the trauma.

The resulting negative protein balance may be associated with immunosuppression; poor wound healing, muscle weakness, reduced survival, increasing length of hospitalization, and the accompanying costs.

Some authors consumed that a good strategy for avoidance or decreasing muscle loss is by adding adequate quantities of protein to the nutritional therapy administered during the acute phase of the disease during ICU stay.

In this regard, the evaluation of skeletal muscles by B- mode Ultra-Sonography is an emerging and reliable tool to assess muscle changes over time. It is a bedside technique, easy to use, and inexpensive.

Patients and methods:

Patients will be randomly classified into 2 groups 1:1 according to their protein intake:

Group I (low normal protein intake group):

Patients in this group will receive protein at (0.8 -1.5 gm/kg/day).

Group II (High normal protein intake group):

Patients in this group will receive protein (1.6 - 2.2 gm/kg/day).

For each patient on 1st day of admission, the following demographics and clinical data will be recorded: age, weight, body mass index (BMI), Glasgow Coma Scale (GCS), blood levels of albumin, total protein, and creatinine, then complete nutritional assessment is done for every patient by modified NUTRIC risk assessment tool.

Nutritional support This study will be carried out on you in the intensive care unit of tufts medical center. Enteral feeding will be started as soon as the condition will be stable, usually within 24 hours. The caloric requirement for you will be detected by indirect calorimetry or calculation (30/35 Kcal/Kg/day) and will be supplied in the form of high caloric Entral formula (1.5kcal/ml, 237ml contains 15.1 g protein) and the protein supplementation will be completed by the addition of enteral supplemental protein (beneprotein) as required to reach the target level of protein to reach at least minimum protein requirement 0.8 grams per kilogram of body weight Tube feeding will be started at a very low rate (10-20 ml/h) and the rate will be increased 25 ml every 6 hours until standard requirements of caloric and protein intake is achieved. The patient's intolerance to feeding is defined based on clinical signs (abdominal distention, vomiting, high gastric residual volume ≥ 500 cc) and will be excluded from the final analysis.

On 1st day of admission to the ICU, you will be intubated, ventilated, and sedated. Imaging by ultrasound on subsequent days will be performed in patients who will be still intubated and ventilated. An ultrasound (US) evaluation of the Rectus Femoris (RF) muscle will be performed on day 0 (within 24 h from admission),1st, and 5th day.

Assessment of Rectus Femoris muscle:

On 1st day of admission, all patients will be intubated, ventilated, and sedated. Imaging on subsequent days will be performed in patients who will be still intubated and ventilated. Skeletal muscles will be evaluated by US scan, collecting both quantitative and qualitative data.

An ultrasound (US) evaluation of the Rectus Femoris(RF) muscle will be performed in all patients on day 0 (within 24 h from trauma),1 st, and 5th day. We will use a US device with a 2- to 5-MHz linear probe. US settings (depth, gain, and focus) will be standardized for RF examination. Excess contact gel will be applied so to minimize underlying soft tissue distortion. The transducer will be placed perpendicular to the long axis of the muscle (i.e., perpendicular to the major axis of the limb), at 3/5 of the distance between the anterior superior iliac spine and the superior border of patella (i.e., about 15 cm from the patella) for the RF. The measurement points will be marked with indelible ink to ensure day-to-day consistency and facilitate subsequent measurements. After freezing the US image, quantitative parameters will be recorded for cross-sectional area (CSA) (computed from the perimetral contour of the muscle section). The value of CSA is considered to be proportional to the total mass of the skeletal muscle. We also will measure the Pennation angle of Rectus femoris (The pennation angle is defined as the angle between muscle fibers and the deep fascia of the muscle). Pennation angles will therefore be measured in the longitudinal ultrasound image as the orientation of the fibers of the rectus femoris was almost parallel to their fascia.

We also will record one qualitative parameter-echogenicity-that is expressed according to the Heckmatt Scale. Increased echogenicity is usually regarded as an index of myofibers depletion.

Measurements and monitoring

  1. Demographic data e.g. age, sex, weight body mass index (BMI), Modified Nutric score.
  2. Quantitative parameters: Pennation angle, the cross-sectional area of rectus femoris muscle: at baseline then at day 1 st, 5th after initiation of nutritional therapy.
  3. Qualitative parameter: Echogenicity by Heckmatt scale: at baseline then at baseline then at day 1 st, 5th after initiation of nutritional therapy.
  4. Serum albumin and total protein at baseline then at day 1 st, and 5th after initiation of nutritional therapy.
  5. Blood urea nitrogen, nitrogen balance at baseline then at day 1 st, 5th after initiation of nutritional therapy.
  6. The length of mechanical ventilation and ICU stay will be estimated and compared in the two groups.
Keywords
protein- enteral- rectus femoris muscle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06012201
Study groupRoleWhat they receive
low normal protein intakethe patient in this group will intake enteral protein feeding from 0.8- 1.5 gm /kg/day
high normal protein intakethe patient in this group will intake enteral protein feeding from 1.6 - 2.2 gm /kg/day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the percentage of reduction in the muscle mass measured by US.

    the percentage of muscle mass change compared to the other group

    Measured: day 0 , 1, and 5 days of ICU admission

Secondary outcomes (12)
  1. Pennation angle of rectus femoris muscle in degrees

    calculate the Pennation angle of rectus femoris compared to the other group

    Measured: day 0 , 1, and 5 days of ICU admission

  2. Length of mechanical ventilation and ICU stay in days

    calculate the duration spent on the ventilator and days spent in the ICU reduced in both groups

    Measured: until discharge or died

  3. age in years

    average age of each group in years and compared to each other

    Measured: at the baseline day (0) of study

  4. weight in kilograms

    weight of each patient in kilograms and compared to each other

    Measured: at the baseline day (0) of study

  5. Body Mass index in Kilogram/meter square

    weight and height will be combined to report BMI in kg/m^2

    Measured: at the baseline day (0) of study

  6. sex predominance in each group

    sex predominance in each group and compare to each other

    Measured: at the baseline day (0) of study

  7. modified nutric score

    International score for evaluation of nutritional status of the each patient in each group

    Measured: at the baseline day (0) of study

  8. cross- sectional area in centimeter

    calculate the cross sectional area of rectus femoris compared to the other group

    Measured: day 0 , 1, and 5 days of ICU admission

  9. Echogenicity by Heckmatt scale

    it is a international scale to detect the echogenecity

    Measured: day 0 , 1, and 5 days of ICU admission

  10. Serum albumin and total protein in grams per deciliter

    measures Serum albumin and total protein for each patient in each group and compare between the two groups

    Measured: day 0 , 1, and 5 days of ICU admission

  11. Blood urea nitrogen in mg/dL

    measures Blood urea nitrogen each patient in each group and compare between the two groups

    Measured: at baseline day (0) then at day 1 st, 5th after initiation of nutritional therapy..

  12. nitrogen balance in gram per day

    measures nitrogen balance for each patient in each group and compare between the two groups

    Measured: at baseline day (0) then at day 1 st, 5th after initiation of nutritional therapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2023
  2. Study start1 Sep 2023 (estimated)
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
Target duration
5 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06012201
Sponsor's protocol ID
STUDY00003291
Status last verified
Aug 2023
First submitted
11 Jan 2023
Last updated
25 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We measure the rectus femoris muscle thickness,pennation angle, cross-sectional area, and echogenicity.

Publications

  • Weijs PJ, Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Oudemans-van Straaten HM, Beishuizen A. Low skeletal muscle area is a risk factor for mortality in mechanically ventilated critically ill patients. Crit Care. 2014 Jan 13;18(2):R12. doi: 10.1186/cc13189.

    PubMed 24410863
  • Hermans G, Van Mechelen H, Clerckx B, Vanhullebusch T, Mesotten D, Wilmer A, Casaer MP, Meersseman P, Debaveye Y, Van Cromphaut S, Wouters PJ, Gosselink R, Van den Berghe G. Acute outcomes and 1-year mortality of intensive care unit-acquired weakness. A cohort study and propensity-matched analysis. Am J Respir Crit Care Med. 2014 Aug 15;190(4):410-20. doi: 10.1164/rccm.201312-2257OC.

    PubMed 24825371
  • 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.

    PubMed 24108501
  • Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.

    PubMed 24247473
  • Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

    PubMed 21470008
  • Cunha HF, Rocha EE, Hissa M. Protein requirements, morbidity and mortality in critically ill patients: fundamentals and applications. Rev Bras Ter Intensiva. 2013 Mar;25(1):49-55. doi: 10.1590/s0103-507x2013000100010.

    PubMed 23887760
  • Ferrie S, Allman-Farinelli M, Daley M, Smith K. Protein Requirements in the Critically Ill: A Randomized Controlled Trial Using Parenteral Nutrition. JPEN J Parenter Enteral Nutr. 2016 Aug;40(6):795-805. doi: 10.1177/0148607115618449. Epub 2015 Dec 3.

    PubMed 26635305
  • Mourtzakis M, Wischmeyer P. Bedside ultrasound measurement of skeletal muscle. Curr Opin Clin Nutr Metab Care. 2014 Sep;17(5):389-95. doi: 10.1097/MCO.0000000000000088.

    PubMed 25023190
  • de Vries MC, Koekkoek WK, Opdam MH, van Blokland D, van Zanten AR. Nutritional assessment of critically ill patients: validation of the modified NUTRIC score. Eur J Clin Nutr. 2018 Mar;72(3):428-435. doi: 10.1038/s41430-017-0008-7. Epub 2017 Nov 23.

    PubMed 29167575

Questions about this trial

What is this clinical trial studying?

An observational study of Atrophy of Rectus Femoris Muscle (Physical Finding), run by Tufts Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact HANAN ELKALAWY, MD (8323750853, helkalawy@tuftsmedicalcenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the percentage of reduction in the muscle mass measured by US. (time frame: day 0 , 1, and 5 days of ICU admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06012201, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.

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