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

Nutrient Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06168136
• Other study ID #: protein on muscle mass in ICU
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: Mohammad Esam, Master
• Phone: +201112554609
• Email: m92beh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 recovery in critically ill patients.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nutrient Deficiency

Intervention

Other:
• protein diet
this group of patients will receive high protein intake (target: 1.8 g protein/kg BW/d)
• Normal protein diet
this group of patients will receive normal protein intake (target: 1.2 g protein/kg BW/d)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Arabi 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. — View Citation

Brook 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. — View Citation

Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29. — View Citation

Long 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 — View Citation

Looijaard 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. — View Citation

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. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul]. — View Citation

van 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. — View Citation

Wandrag 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring muscle mass changes in response to high protein intake	muscle mass using ultrasound and laboratory: titre of CK (Creatinine kinase) level.	one year
Secondary	- 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	one year