Nutrient DeficiencyNCT06168136
Effects of Medical High Protein Nutrition on the Muscle Mass in Adult ICU Patients
A study testing protein diet and Normal protein diet in people with Nutrient Deficiency, run by Assiut University.
Trial summary
The use of ultrasound in clinical practice is feasible for monitoring muscle mass in critically ill patients. Assessment of muscle mass by ultrasound is clinically relevant and adds value for guiding therapeutic interventions, such as nutritional and physical therapy interventions to maintain muscle mass and promote… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrient Deficiency
- What is being tested?
- protein diet and Normal protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Feb 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all critically ill-patients with Acute Physiologic Assessment and Chronic Health Evaluation II (8) (APACHE II score ) ≥ 25 and could be enterally or parenterally fed in the critical care unit of Assiut University Hospitals.
Who cannot join
- patients with malabsorption syndrome, previously diagnosed myopathies, traumatic brain injuries, intracerebral hemorrhages and cerebral ischemia.
Trial locations and contacts
No sites are listed yet.
About this study
The use of ultrasound in clinical practice is feasible for monitoring muscle mass in critically ill patients. Assessment of muscle mass by ultrasound is clinically relevant and adds value for guiding therapeutic interventions, such as nutritional and physical therapy interventions to maintain muscle mass and promote recovery in critically ill patients.
Read the detailed description
Critical illness is characterized by substantial hormone- and cytokine-mediated protein metabolism changes in various organs, leading to increased breakdown and decreased synthesis rates. Consequently, a considerable and life-threatening loss of muscle mass occurs. Medical therapeutic measures such as long-term sedation and mechanical ventilation during ICU stay can further enhance this muscle degradation (up to 2 % muscle mass per day leading to clinically relevant symptoms known as ICU-acquired weakness. Nutritional modulation, particularly of dietary amino acids, may have benefits to prevent or attenuate disease-induced muscle wasting. while there are several accurate muscle mass measurement methods and techniques [including computed tomography (CT) scan, bio-impedance analysis and ultrasound], not all are routinely feasible in clinical ICU practice. The use of ultrasound in assessing muscle mass in critically ill patients has gained much attention recently as it is non-invasive and can easily be utilized at the bedside. There are two main goals for the assessment of muscle mass: first, to assess the current muscle mass for the patient as part of (nutritional) diagnosis, and thereby risk stratification and second, to monitor the progression of muscle loss and/or recovery of muscle mass, and create opportunity to examine the effectiveness of therapeutic interventions to reduce muscle loss and/or promote muscle recovery.
- Conditions
- Nutrient Deficiency
- Being tested
- protein diet, Normal protein diet
- Keywords
- muscle ultrasound, nutrition, protein diet, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein dietOther
this group of patients will receive high protein intake (target: 1.8 g protein/kg BW/d)
Normal protein dietOther
this group of patients will receive normal protein intake (target: 1.2 g protein/kg BW/d)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Group A: included (42) patients who will receive high protein intake (target: 1.8 g protein/kg body weight /d). Receives: Other: protein diet |
| Control | Other | Group B: included (42) patients who will receive Standard of nutrition Care: (target: 1.2 g protein/kg body weight /d) Receives: Other: Normal protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring muscle mass changes in response to high protein intake
muscle mass using ultrasound and laboratory: titre of CK (Creatinine kinase) level.
Measured: one year
Secondary outcomes (1)
- Duration of mechanical ventilation in days. - Improvement of APACHE II score. - Duration of hospital stay in days. - Early ambulation of patients in days. - In hospital mortality.
APACHE II score is Acute Physiology and Chronic Health Evaluation II: an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nutrient DeficiencyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Esam, Assiut University
- Investigators
- Mohammad Esam, Master, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168136
- Sponsor's protocol ID
- protein on muscle mass in ICU
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 24108501Wandrag L, Brett SJ, Frost GS, Bountziouka V, Hickson M. Exploration of muscle loss and metabolic state during prolonged critical illness: Implications for intervention? PLoS One. 2019 Nov 14;14(11):e0224565. doi: 10.1371/journal.pone.0224565. eCollection 2019.
PubMed 31725748Arabi YM, Al-Dorzi HM, Sadat M. Protein intake and outcome in critically ill patients. Curr Opin Clin Nutr Metab Care. 2020 Jan;23(1):51-58. doi: 10.1097/MCO.0000000000000619.
PubMed 31743123Brook MS, Wilkinson DJ, Atherton PJ. Nutrient modulation in the management of disease-induced muscle wasting: evidence from human studies. Curr Opin Clin Nutr Metab Care. 2017 Nov;20(6):433-439. doi: 10.1097/MCO.0000000000000413.
PubMed 28832372Looijaard WGPM, Molinger J, Weijs PJM. Measuring and monitoring lean body mass in critical illness. Curr Opin Crit Care. 2018 Aug;24(4):241-247. doi: 10.1097/MCC.0000000000000511.
PubMed 29847342van Ruijven IM, Stapel SN, Molinger J, Weijs PJM. Monitoring muscle mass using ultrasound: a key role in critical care. Curr Opin Crit Care. 2021 Aug 1;27(4):354-360. doi: 10.1097/MCC.0000000000000846.
PubMed 33973896Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
PubMed 3928249Long CL, Schaffel N, Geiger JW, Schiller WR, Blakemore WS. Metabolic response to injury and illness: estimation of energy and protein needs from indirect calorimetry and nitrogen balance. JPEN J Parenter Enteral Nutr. 1979 Nov-Dec;3(6):452-6. doi: 10.1177/014860717900300609.
PubMed 575168
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Medical High Protein Nutrition on the Muscle Mass in Adult ICU Patients
- ClinicalTrials.gov ID
- NCT06168136
- Acronym / sponsor ID
- protein on muscle mass in ICU
- Conditions
- Nutrient Deficiency
- Keywords
- muscle ultrasound, nutrition, protein diet, ICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 13 Dec 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.
The use of ultrasound in clinical practice is feasible for monitoring muscle mass in critically ill patients. Assessment of muscle mass by ultrasound is clinically relevant and adds value for guiding therapeutic interventions, such as nutritional and physical therapy interventions to maintain muscle mass and promote recovery in critically ill patients.
Detailed description
Critical illness is characterized by substantial hormone- and cytokine-mediated protein metabolism changes in various organs, leading to increased breakdown and decreased synthesis rates. Consequently, a considerable and life-threatening loss of muscle mass occurs. Medical therapeutic measures such as long-term sedation and mechanical ventilation during ICU stay can further enhance this muscle degradation (up to 2 % muscle mass per day leading to clinically relevant symptoms known as ICU-acquired weakness. Nutritional modulation, particularly of dietary amino acids, may have benefits to prevent or attenuate disease-induced muscle wasting. while there are several accurate muscle mass measurement methods and techniques [including computed tomography (CT) scan, bio-impedance analysis and ultrasound], not all are routinely feasible in clinical ICU practice. The use of ultrasound in assessing muscle mass in critically ill patients has gained much attention recently as it is non-invasive and can easily be utilized at the bedside. There are two main goals for the assessment of muscle mass: first, to assess the current muscle mass for the patient as part of (nutritional) diagnosis, and thereby risk stratification and second, to monitor the progression of muscle loss and/or recovery of muscle mass, and create opportunity to examine the effectiveness of therapeutic interventions to reduce muscle loss and/or promote muscle recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: protein dietGroup A: included (42) patients who will receive high protein intake (target: 1.8 g protein/kg body weight /d). |
| Control | Other | Other: Normal protein dietGroup B: included (42) patients who will receive Standard of nutrition Care: (target: 1.2 g protein/kg body weight /d) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all critically ill-patients with Acute Physiologic Assessment and Chronic Health Evaluation II (8) (APACHE II score ) ≥ 25 and could be enterally or parenterally fed in the critical care unit of Assiut University Hospitals.
Key exclusion criteria (1 listed)
- patients with malabsorption syndrome, previously diagnosed myopathies, traumatic brain injuries, intracerebral hemorrhages and cerebral ischemia.
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 |
|---|---|---|
| protein dietthis group of patients will receive high protein intake (target: 1.8 g protein/kg BW/d) | Other | Intervention |
| Normal protein dietthis group of patients will receive normal protein intake (target: 1.2 g protein/kg BW/d) | Other | Control |
Primary outcome
Monitoring muscle mass changes in response to high protein intake
Time frame: one year
muscle mass using ultrasound and laboratory: titre of CK (Creatinine kinase) level.
1 secondary outcome
- Duration of mechanical ventilation in days. - Improvement of APACHE II score. - Duration of hospital stay in days. - Early ambulation of patients in days. - In hospital mortality.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- 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 31725748Wandrag L, Brett SJ, Frost GS, Bountziouka V, Hickson M. Exploration of muscle loss and metabolic state during prolonged critical illness: Implications for intervention? PLoS One. 2019 Nov 14;14(11):e0224565. doi: 10.1371/journal.pone.0224565. eCollection 2019.
- Background: PubMed 31743123Arabi YM, Al-Dorzi HM, Sadat M. Protein intake and outcome in critically ill patients. Curr Opin Clin Nutr Metab Care. 2020 Jan;23(1):51-58. doi: 10.1097/MCO.0000000000000619.
- Background: PubMed 28832372Brook MS, Wilkinson DJ, Atherton PJ. Nutrient modulation in the management of disease-induced muscle wasting: evidence from human studies. Curr Opin Clin Nutr Metab Care. 2017 Nov;20(6):433-439. doi: 10.1097/MCO.0000000000000413.
- Background: PubMed 29847342Looijaard WGPM, Molinger J, Weijs PJM. Measuring and monitoring lean body mass in critical illness. Curr Opin Crit Care. 2018 Aug;24(4):241-247. doi: 10.1097/MCC.0000000000000511.
- Background: PubMed 33973896van Ruijven IM, Stapel SN, Molinger J, Weijs PJM. Monitoring muscle mass using ultrasound: a key role in critical care. Curr Opin Crit Care. 2021 Aug 1;27(4):354-360. doi: 10.1097/MCC.0000000000000846.
- Background: PubMed 3928249Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
- Results publication: PubMed 575168Long CL, Schaffel N, Geiger JW, Schiller WR, Blakemore WS. Metabolic response to injury and illness: estimation of energy and protein needs from indirect calorimetry and nitrogen balance. JPEN J Parenter Enteral Nutr. 1979 Nov-Dec;3(6):452-6. doi: 10.1177/014860717900300609.
- Individual participant dataSharing planned: No
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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.
Mohammad Esam, Master principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing protein diet and Normal protein diet in people with Nutrient Deficiency, run by Assiut University.
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 1 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 13 Dec 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 Mohammad Esam, Master (+201112554609, m92beh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring muscle mass changes in response to high protein intake (time frame: one year). 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 NCT06168136, which also lists 8 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 13 Dec 2023.