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Effects of Medical High Protein Nutrition on the Muscle Mass in Adult ICU Patients

Effects of Medical High Protein Nutrition on the Muscle Mass in Adult ICU Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06168136
Enrollment
84
Registered
2023-12-13
Start date
2024-01-01
Completion date
2025-02-01
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrient Deficiency

Keywords

muscle ultrasound, nutrition, protein diet, ICU

Brief 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 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.

Interventions

this group of patients will receive high protein intake (target: 1.8 g protein/kg BW/d)

this group of patients will receive normal protein intake (target: 1.2 g protein/kg BW/d)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* patients with malabsorption syndrome, previously diagnosed myopathies, traumatic brain injuries, intracerebral hemorrhages and cerebral ischemia.

Design outcomes

Primary

MeasureTime frameDescription
Monitoring muscle mass changes in response to high protein intakeone yearmuscle mass using ultrasound and laboratory: titre of CK (Creatinine kinase) level.

Secondary

MeasureTime frameDescription
- 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.one yearAPACHE 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

Contacts

Primary ContactMohammad Esam, Master
m92beh@gmail.com+201112554609

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026