The Relation Between Quadriceps Muscle Layer Thickness and Nitrogen Balance for Nutrition Monitoring (NCT04303650) | Clinical Trial Compass
CompletedNot Applicable
The Relation Between Quadriceps Muscle Layer Thickness and Nitrogen Balance for Nutrition Monitoring
Egypt186 participantsStarted 2020-03-15
Plain-language 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.
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
correlation between Nitrogen Balance and quadriceps muscle layer thickness (QMLT)