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

NCT06168136 | Unknown DMC

• 1 other identifier: protein on muscle mass in ICU
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nutrient Deficiency

Keywords

muscle ultrasound; nutrition; protein diet; ICU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• - 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 year

Study Arms (2)

Intervention

OTHER

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

Other: protein diet

Control

OTHER

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

Other: Normal protein diet

Interventions

protein diet OTHER

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

Intervention

Normal protein diet OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• 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.

  PMID: 24108501 BACKGROUND

• 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.

  PMID: 31725748 BACKGROUND

• 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.

  PMID: 31743123 BACKGROUND

• 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.

  PMID: 28832372 BACKGROUND

• 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.

  PMID: 29847342 BACKGROUND

• 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.

  PMID: 33973896 BACKGROUND

• 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.

  PMID: 3928249 BACKGROUND

• 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.

  PMID: 575168 RESULT

Study Officials

• Mohammad Esam, Master

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Esam, Master

CONTACT

+201112554609; m92beh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 13, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share