TraumaNCT04303650
The Relation Between Quadriceps Muscle Layer Thickness and Nitrogen Balance for Nutrition Monitoring
An observational study of Trauma, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trauma
- What is being tested?
- Ultrasound measurement of quadriceps muscle layer thickness
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 186 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2020to 30 Nov 2023
- How long will I take part?
- 28 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Critically ill trauma patients aged between 18 - 60 years of both sexes
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Emergency and Surgical Intensive Care Units, Zagazig University Hospitals
Zagazig, Sharqia Province, 44111
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma
- Being tested
- Ultrasound measurement of quadriceps muscle layer thickness
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound measurement of quadriceps muscle layer thicknessDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between Nitrogen Balance and quadriceps muscle layer thickness (QMLT)
To determine the correlation between Nitrogen Balance and QMLT detected by ultrasound
Measured: 10 days
Secondary outcomes (2)
relationship between QMLT, pre-albumin, and CRP
To determine the correlation between pre-albumin and CRP and QMLT detected by ultrasound
Measured: 10 days
The impact of QMLT and NB on 28 day mortality.
To determine the correlation between nitrogen balance and QMLT detected by ultrasound and the outcome by 28 day mortality.
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start15 Mar 2020
- Primary completion30 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies 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
- 186 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sherif M. S. Mowafy, Zagazig University
- Investigators
- Fatma M Ahmed, MD, Study director, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig UniversitySherif MS Mowafy, MD, Principal investigator, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303650
- Sponsor's protocol ID
- 5968-5-3-2020
- Status last verified
- Dec 2023
- First submitted
- 8 Mar 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in the publication
Publications
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.
PubMed 25733640Fock 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.
PubMed 20036516Rai 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.
PubMed 12002213Latronico 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.
PubMed 28289812Andonovska, 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
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.
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 24108501Nakanishi 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.
PubMed 29110031Price 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.
PubMed 30377307Weinel 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.
PubMed 31640395McClave 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.
PubMed 26773077Singer 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.
PubMed 30348463
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Sonographic Quadriceps Muscle Layer Thickness and Nitrogen Balance for Nutrition Monitoring in Adult Critically Ill Trauma Patients
- ClinicalTrials.gov ID
- NCT04303650
- Acronym / sponsor ID
- 5968-5-3-2020
- Conditions
- Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 11 Mar 2020 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Critically ill trauma patients aged between 18 - 60 years of both sexes
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound measurement of quadriceps muscle layer thicknessWith 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 | Device | – |
Primary outcome
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
2 secondary outcomes
relationship between QMLT, pre-albumin, and CRP
Time frame: 10 days
The impact of QMLT and NB on 28 day mortality.
Time frame: 28 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 25733640Liebau 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.
- Background: PubMed 20036516Fock 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.
- Background: PubMed 12002213Rai 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.
- Background: PubMed 28289812Latronico 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.
- BackgroundAndonovska, 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
- BackgroundFelicetti-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: 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.
- Background: PubMed 29110031Nakanishi 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.
- Background: PubMed 30377307Price 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.
- Background: PubMed 31640395Weinel 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.
- Background: PubMed 26773077McClave 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.
- Background: PubMed 30348463Singer 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in the publication
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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.
Fatma M Ahmed, MD study director
Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
Sherif MS Mowafy, MD principal investigator
Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between Nitrogen Balance and quadriceps muscle layer thickness (QMLT) (time frame: 10 days). 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 NCT04303650, which also lists 12 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 5 Dec 2023.