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

NCT ID: NCT06168136

Last Updated: 2023-12-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-02-01

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.

Conditions

Nutrient Deficiency

Keywords

muscle ultrasound; nutrition; protein diet; ICU

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Group A: included (42) patients who will receive high protein intake (target: 1.8 g protein/kg body weight /d).

Group Type: OTHER

protein diet

Intervention Type: OTHER

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

Control

Group B: included (42) patients who will receive Standard of nutrition Care: (target: 1.2 g protein/kg body weight /d)

Group Type: OTHER

Normal protein diet

Intervention Type: OTHER

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

Interventions

protein diet

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

Intervention Type: OTHER

Normal protein diet

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Esam

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad Esam, Master

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Mohammad Esam, Master

Role: CONTACT

Phone: +201112554609

Email: m92beh@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 24108501 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31725748 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31743123 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28832372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29847342 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33973896 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3928249 (View on PubMed)

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: 10.1177/014860717900300609.

Reference Type: RESULT

PMID: 575168 (View on PubMed)

Other Identifiers

protein on muscle mass in ICU

Identifier Type: -

Identifier Source: org_study_id