ICU Acquired WeaknessNCT06025760
Evaluation of Diaphragmatic Function and Quadriceps Muscle Thickness in Patients Receiving High Protein Nutrition
A study testing patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness in people with ICU Acquired Weakness, run by Zagazig University.
Trial summary
Different Protein Doses' Effect on Diaphragmatic Function and Quadriceps Thickness Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ICU Acquired Weakness
- What is being tested?
- patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Nov 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Acceptance of the first-degree relatives.
- Critically ill patients: patients with a life-threatening condition that requires pharmacological and/or mechanical support of vital organ functions without which death would be imminent.
- Patients anticipated to be mechanically ventilated for ≥ 48 hours
- Patients who expected ICU stay ≥ 4 weeks
- Patients aged between 18 - 60 years of both sexes.
- Patient nutrition risk screening (NRS 2002) score ≥ 3
- Patient BMI less than 35
- No contraindication to early enteral nutrition.
Who cannot join
- • Patient with Trauma to both lower extremities, diaphragm disease (trauma, immobilization….), myopathy, and moderate to severe hepatic insufficiency.
- Patient receiving steroids.
- Patient on renal replacement therapy.
- Prior MV before admission.
- Pregnant.
- Patient with neuromuscular disease, spinal cord injury, thoracic deformity, and respiratory restriction.
- Patients require muscle paralysis on MV.
- Patients require high dose inotrope or vasopressor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Diaphragmatic Function and Quadriceps Muscle Thickness Using Ultrasonography in Critically Ill Mechanically Ventilated Patients Receiving High Protein Nutrition
Different Protein Doses' Effect on Diaphragmatic Function and Quadriceps Thickness
Read the detailed description
Nutrition therapy is no longer a support method for critically ill patients but is considered an important treatment measure. Increasing the protein and energy available to patients in the intensive care unit (ICU) reduces infection and complications, increases ventilator-free days, increases long-term physical recovery, and lowers patient mortality Among critically ill patients, protein is the most important macronutrient because it promotes healing, improves immune function, and helps patients maintain their lean body mass. Growing evidence has shown that adequate protein intake may be more important than caloric intake in the body. In addition, reaching at least 80% of the prescribed protein intake rather than energy intake is related to improved survival rates in ICU patients.
Muscular atrophy is a common feature in patients with intensive care unit-acquired weakness (ICU-AW), and it can start in the early stages of critical illness (within hours of onset of the disease). Its development has been related to the acute inflammatory process and immobilization. Factors such as age, medications, comorbidities, nutrition, and nervous, and muscular damage before critical illness can contribute to the extent of atrophy and the muscular and functional recovery capacity.
It was believed that perhaps the respiratory muscles in humans were spared any loss of muscle protein during starvation because of their constant activity. In a necropsy study designed to assess the diaphragm in health and disease, it was found that alterations in body weight and muscularity profoundly affect the diaphragm muscle mass.
Mechanical ventilation (MV) is the most important life-sustaining measure for critically ill patients, Even if the MV is maintained for a short time, diaphragm fatigue may also occur owing to atrophy or decreased contractile function, which is known as ventilator-induced diaphragm dysfunction (VIDD). Pathophysiological changes of VIDD include muscle atrophy, structural damage, and fiber-type transformation and remodeling.VIDD is the main factor contributing to difficult weaning from long-term MV in critically ill patients. Prolonging the time of MV is associated with an increased risk of complications, long-term dysfunction, and death.
Muscles of the lower limb are more prone to early atrophy as they are weight-bearing compared to the muscles of the upper limb as shown in previous studies. The authors showed that the size of the flexor compartment of the elbow did not show any change in the first 10 days of admission, whereas the size of the anterior compartment muscles of the lower limb showed a greater decrease in thickness within the first 5 days. Thus, these muscles make a good choice for muscle mass assessment.
Point-of-care ultrasound (POCUS) is rapid, accurate, repeatable, nonexpensive, noninvasive, and without the risk of radiation. It can visualize a large muscle area and deeper-located muscles. It can be used in both stable and unstable patients. Performing repeated ultrasound examinations in critical patients is essential and improves the overall sensitivity of the examination, which has become a standard of care in critical care.
One of the unsolved problems for a reliable definition of protein goals is the optimal intake timing to reach predefined therapeutic goals. European Society for Clinical Nutrition and Metabolism (ESPEN) 2009 recommended protein dose to be 1.2 - 1.5 gm /kg/day, while recent ESPEN 2019 guidelines recommend a dose of 1.3 gm/kg/day. On the other hand, the American Society for Parenteral and Enteral Nutrition (ASPEN) 2016 and ASPEN 2022 recommend a dose of 1.2- 2 gm/kg/day.
Generally, it is well known that patients in the acute phase (ebb phase) of the stress response are less capable of utilizing nutrients, thereby implying that early high-dose protein administration might not be beneficial. In the later phase (flow phase) of metabolic stress, insulin sensitivity gradually improves, and the human body's capability to metabolize exogenous substrates increases accordingly.
- Conditions
- ICU Acquired Weakness
- Being tested
- patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thicknessOther
Also called patients who will receive 1.2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness in
All patients after ICU admission will be started enteral nutrition through a nasogastric tube within 24-48 hours. The target caloric intake is 25-30 kcal/kg/day. patients in the interventional group will receive 2 gm protein/kg/day, while patients in the control group will receive 1.2 gm protein/kg/day. Quadriceps thickness and Diaphragm thickening fraction will be assessed by ultrasound from the time of admission on days 0, 3, 5, and 7 then weekly till the fourth week.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Active comparator | Mechanically ventilated patients will receive a nutritional caloric intake of 25-30 kcal/kg/day with a high protein dose of 2 gm protein /kg/day within 24 hours of ICU admission. Receives: Other: patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness |
| Control group | Placebo comparator | patients will receive a nutritional caloric intake of 25-30 kcal/kg/day with a standard protein dose of 1.2 gm protein /kg/day within 24 hours of ICU admission. Receives: Other: patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of different protein doses (1.2 gm/kg per day versus 2 gm/kg per day ) on diaphragmatic muscle function in mechanically ventilated patients in ICU for 4 weeks.
assessment of the effect of different protein doses per day on diaphragmatic muscle function in mechanically ventilated patients using ultrasound, the following data will be assessed:
- Diaphragm thickness (mm) on days (0, 3, 5, and 7 from ICU admission then weekly till the fourth week ).
- Diaphragm thickening fraction on the day (0, 3, 5, 7 then weekly till the fourth week )
- Diaphragm excursion during the weaning trial during spontaneous breathing trial (SBT).
Measured: from time of ICU admission on day 0,then on days 3, 5, 7, then weekly till the fourth week.
Secondary outcomes (1)
To assess the effect of different protein doses (1.2 gm/kg per day versus 2 gm/kg per day ) on Quadriceps muscle thickness(mm) in mechanically ventilated patients in ICU for 4 weeks.
Assessment of the effect of different protein doses per day on quadriceps muscle layer thickness (mm) in mechanically ventilated patients in ICU using ultrasound, the following data will be assessed :
Quadriceps muscle layer thickness on the day (0, 3, 5, 7, from ICU admission then weekly till the fourth week )
Measured: from time of ICU admission on day 0, then on days 3, 5, 7, then weekly till the fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Critically ill mechanically ventilated patients will receive protein of 2 gm/kg/day in the interventional group. Critically ill mechanically ventilated patients will receive protein of 1.2 gm/kg/day in the control group.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Naglaa Fathy Abdelhaleem Abdelhaleem, Zagazig University
- Investigators
- Ghada Abdelrazik, professor, Study chair, Professor of anesthesia, intensive care and pain managmentNeven Gamil, professor, Study chair, Professor of anesthesia, intensive care and pain managmentNaglaa Abdelhaleem, Lecturer, Study chair, lecturer of anesthesia, intensive care and pain managmentAyman Amer, professor, Study chair, Professor of diagnostic radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025760
- Sponsor's protocol ID
- IRB#9659
- Status last verified
- Aug 2023
- First submitted
- 6 Dec 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diaphragmatic Function and Quadriceps Muscle Thickness Using Ultrasonography in Critically Ill Mechanically Ventilated Patients Receiving High Protein Nutrition
- ClinicalTrials.gov ID
- NCT06025760
- Acronym / sponsor ID
- IRB#9659
- Conditions
- ICU Acquired Weakness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 6 Sep 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.
Different Protein Doses' Effect on Diaphragmatic Function and Quadriceps Thickness
Detailed description
Nutrition therapy is no longer a support method for critically ill patients but is considered an important treatment measure. Increasing the protein and energy available to patients in the intensive care unit (ICU) reduces infection and complications, increases ventilator-free days, increases long-term physical recovery, and lowers patient mortality Among critically ill patients, protein is the most important macronutrient because it promotes healing, improves immune function, and helps patients maintain their lean body mass. Growing evidence has shown that adequate protein intake may be more important than caloric intake in the body. In addition, reaching at least 80% of the prescribed protein intake rather than energy intake is related to improved survival rates in ICU patients.
Muscular atrophy is a common feature in patients with intensive care unit-acquired weakness (ICU-AW), and it can start in the early stages of critical illness (within hours of onset of the disease). Its development has been related to the acute inflammatory process and immobilization. Factors such as age, medications, comorbidities, nutrition, and nervous, and muscular damage before critical illness can contribute to the extent of atrophy and the muscular and functional recovery capacity.
It was believed that perhaps the respiratory muscles in humans were spared any loss of muscle protein during starvation because of their constant activity. In a necropsy study designed to assess the diaphragm in health and disease, it was found that alterations in body weight and muscularity profoundly affect the diaphragm muscle mass.
Mechanical ventilation (MV) is the most important life-sustaining measure for critically ill patients, Even if the MV is maintained for a short time, diaphragm fatigue may also occur owing to atrophy or decreased contractile function, which is known as ventilator-induced diaphragm dysfunction (VIDD). Pathophysiological changes of VIDD include muscle atrophy, structural damage, and fiber-type transformation and remodeling.VIDD is the main factor contributing to difficult weaning from long-term MV in critically ill patients. Prolonging the time of MV is associated with an increased risk of complications, long-term dysfunction, and death.
Muscles of the lower limb are more prone to early atrophy as they are weight-bearing compared to the muscles of the upper limb as shown in previous studies. The authors showed that the size of the flexor compartment of the elbow did not show any change in the first 10 days of admission, whereas the size of the anterior compartment muscles of the lower limb showed a greater decrease in thickness within the first 5 days. Thus, these muscles make a good choice for muscle mass assessment.
Point-of-care ultrasound (POCUS) is rapid, accurate, repeatable, nonexpensive, noninvasive, and without the risk of radiation. It can visualize a large muscle area and deeper-located muscles. It can be used in both stable and unstable patients. Performing repeated ultrasound examinations in critical patients is essential and improves the overall sensitivity of the examination, which has become a standard of care in critical care.
One of the unsolved problems for a reliable definition of protein goals is the optimal intake timing to reach predefined therapeutic goals. European Society for Clinical Nutrition and Metabolism (ESPEN) 2009 recommended protein dose to be 1.2 - 1.5 gm /kg/day, while recent ESPEN 2019 guidelines recommend a dose of 1.3 gm/kg/day. On the other hand, the American Society for Parenteral and Enteral Nutrition (ASPEN) 2016 and ASPEN 2022 recommend a dose of 1.2- 2 gm/kg/day.
Generally, it is well known that patients in the acute phase (ebb phase) of the stress response are less capable of utilizing nutrients, thereby implying that early high-dose protein administration might not be beneficial. In the later phase (flow phase) of metabolic stress, insulin sensitivity gradually improves, and the human body's capability to metabolize exogenous substrates increases accordingly.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Critically ill mechanically ventilated patients will receive protein of 2 gm/kg/day in the interventional group. Critically ill mechanically ventilated patients will receive protein of 1.2 gm/kg/day in the control group.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Active comparator | Other: patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thicknessMechanically ventilated patients will receive a nutritional caloric intake of 25-30 kcal/kg/day with a high protein dose of 2 gm protein /kg/day within 24 hours of ICU admission. |
| Control group | Placebo comparator | Other: patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thicknesspatients will receive a nutritional caloric intake of 25-30 kcal/kg/day with a standard protein dose of 1.2 gm protein /kg/day within 24 hours of ICU admission. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Acceptance of the first-degree relatives.
Key exclusion criteria (8 listed)
- • Patient with Trauma to both lower extremities, diaphragm disease (trauma, immobilization….), myopathy, and moderate to severe hepatic insufficiency.
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 |
|---|---|---|
| patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thicknessAlso: patients who will receive 1.2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness inAll patients after ICU admission will be started enteral nutrition through a nasogastric tube within 24-48 hours. The target caloric intake is 25-30 kcal/kg/day. patients in the interventional group will receive 2 gm protein/kg/day, while patients in the control group will receive 1.2 gm protein/kg/day. Quadriceps thickness and Diaphragm thickening fraction will be assessed by ultrasound from the time of admission on days 0, 3, 5, and 7 then weekly till the fourth week. | Other | Control group, Interventional group |
Primary outcome
To assess the effect of different protein doses (1.2 gm/kg per day versus 2 gm/kg per day ) on diaphragmatic muscle function in mechanically ventilated patients in ICU for 4 weeks.
Time frame: from time of ICU admission on day 0,then on days 3, 5, 7, then weekly till the fourth week.
assessment of the effect of different protein doses per day on diaphragmatic muscle function in mechanically ventilated patients using ultrasound, the following data will be assessed: 1. Diaphragm thickness (mm) on days (0, 3, 5, and 7 from ICU admission then weekly till the fourth week ). 2. Diaphragm thickening fraction on the day (0, 3, 5, 7 then weekly till the fourth week ) 3. Diaphragm excursion during the weaning trial during spontaneous breathing trial (SBT).
1 secondary outcome
To assess the effect of different protein doses (1.2 gm/kg per day versus 2 gm/kg per day ) on Quadriceps muscle thickness(mm) in mechanically ventilated patients in ICU for 4 weeks.
Time frame: from time of ICU admission on day 0, then on days 3, 5, 7, then weekly till the fourth week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No. Not decided yet
Related trials for ICU Acquired Weakness
Recruiting
Blood Flow Restriction Training for Mechanically Ventilated Patients With ICU-Acquired Weakness
Intensive Care Unit Acquired Weakness
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
Not yet recruiting
Evidence-based, Customized, Motion-recognition Rehabilitation System Development for Bed-ridden Patients - Validation of Effectiveness: Rehabit: Swim
ICU-acquired Weakness
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruiting
Beyond Voluntary Effort: Reliability and Validity of Magnetic Femoral Nerve Stimulation for Assessing Quadriceps Strength in Critically Ill Patient
Critical Illness, ICU-acquired Weakness
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.
Ghada Abdelrazik, professor study chair
Professor of anesthesia, intensive care and pain managment
Neven Gamil, professor study chair
Professor of anesthesia, intensive care and pain managment
Naglaa Abdelhaleem, Lecturer study chair
lecturer of anesthesia, intensive care and pain managment
Questions about this trial
What is this clinical trial studying?
A study testing patients who will receive 2 gm protein/kg/day will be evaluated by ultrasound for diaphragmatic function and quadriceps muscle thickness in people with ICU Acquired Weakness, run by Zagazig 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 8 inclusion and 8 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 14 Sep 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. Some participants in this study may receive a placebo. 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 Mahmoud Aboulaban, A. Lecturer (01013015577, mahmoudaboulaban@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effect of different protein doses (1.2 gm/kg per day versus 2 gm/kg per day ) on diaphragmatic muscle function in mechanically ventilated patients in ICU for 4 weeks. (time frame: from time of ICU admission on day 0,then on days 3, 5, 7, then weekly till the fourth week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2023.