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.
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
- Conditions the study is for
- Atrophy of Rectus Femoris Muscle (Physical Finding)
- 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
- Demographic data e.g. age, sex, weight body mass index (BMI), Modified Nutric score.
- 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.
- Qualitative parameter: Echogenicity by Heckmatt scale: at baseline then at baseline then at day 1 st, 5th after initiation of nutritional therapy.
- Serum albumin and total protein at baseline then at day 1 st, and 5th after initiation of nutritional therapy.
- Blood urea nitrogen, nitrogen balance at baseline then at day 1 st, 5th after initiation of nutritional therapy.
- 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 group | Role | What they receive |
|---|---|---|
| low normal protein intake | the patient in this group will intake enteral protein feeding from 0.8- 1.5 gm /kg/day | |
| high normal protein intake | the 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.
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)
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
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
age in years
average age of each group in years and compared to each other
Measured: at the baseline day (0) of study
weight in kilograms
weight of each patient in kilograms and compared to each other
Measured: at the baseline day (0) of study
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
sex predominance in each group
sex predominance in each group and compare to each other
Measured: at the baseline day (0) of study
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
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
Echogenicity by Heckmatt scale
it is a international scale to detect the echogenecity
Measured: day 0 , 1, and 5 days of ICU admission
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
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..
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.
- First posted25 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Atrophy of Rectus Femoris Muscle (Physical Finding)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PAVAN SEKHAR, MD, Principal investigator, Tufts Medical Center
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 24410863Hermans 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 24825371Puthucheary 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 24108501Fan 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 24247473Herridge 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 21470008Cunha 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 23887760Ferrie 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 26635305Mourtzakis 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 25023190de 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Protein Intake and ICU Skeletal Muscle Weakness
- ClinicalTrials.gov ID
- NCT06012201
- Acronym / sponsor ID
- STUDY00003291
- Keywords
- protein- enteral- rectus femoris muscle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Demographic data e.g. age, sex, weight body mass index (BMI), Modified Nutric score.
- 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.
- Qualitative parameter: Echogenicity by Heckmatt scale: at baseline then at baseline then at day 1 st, 5th after initiation of nutritional therapy.
- Serum albumin and total protein at baseline then at day 1 st, and 5th after initiation of nutritional therapy.
- Blood urea nitrogen, nitrogen balance at baseline then at day 1 st, 5th after initiation of nutritional therapy.
- The length of mechanical ventilation and ICU stay will be estimated and compared in the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low normal protein intake | – | –the patient in this group will intake enteral protein feeding from 0.8- 1.5 gm /kg/day |
| high normal protein intake | – | –the patient in this group will intake enteral protein feeding from 1.6 - 2.2 gm /kg/day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the percentage of reduction in the muscle mass measured by US.
Time frame: day 0 , 1, and 5 days of ICU admission
the percentage of muscle mass change compared to the other group
12 secondary outcomes
Pennation angle of rectus femoris muscle in degrees
Time frame: day 0 , 1, and 5 days of ICU admission
Length of mechanical ventilation and ICU stay in days
Time frame: until discharge or died
age in years
Time frame: at the baseline day (0) of study
weight in kilograms
Time frame: at the baseline day (0) of study
Body Mass index in Kilogram/meter square
Time frame: at the baseline day (0) of study
sex predominance in each group
Time frame: at the baseline day (0) of study
modified nutric score
Time frame: at the baseline day (0) of study
cross- sectional area in centimeter
Time frame: day 0 , 1, and 5 days of ICU admission
Echogenicity by Heckmatt scale
Time frame: day 0 , 1, and 5 days of ICU admission
Serum albumin and total protein in grams per deciliter
Time frame: day 0 , 1, and 5 days of ICU admission
Blood urea nitrogen in mg/dL
Time frame: at baseline day (0) then at day 1 st, 5th after initiation of nutritional therapy..
nitrogen balance in gram per day
Time frame: at baseline day (0) then at day 1 st, 5th after initiation of nutritional therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Results publication: PubMed 24410863Weijs 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.
- Results publication: PubMed 24825371Hermans 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.
- Results publication: PubMed 24108501Puthucheary 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.
- Results publication: PubMed 24247473Fan 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.
- Results publication: PubMed 21470008Herridge 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.
- Results publication: PubMed 23887760Cunha 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.
- Results publication: PubMed 26635305Ferrie 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.
- Results publication: PubMed 25023190Mourtzakis 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.
- Results publication: PubMed 29167575de 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.
- Individual participant dataSharing planned: Undecided. We measure the rectus femoris muscle thickness,pennation angle, cross-sectional area, and echogenicity.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PAVAN SEKHAR, MD principal investigator
Tufts Medical Center
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.