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

December 10, 2023 updated by: Mohammed Esam, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohammad Esam, Master
  • Phone Number: +201112554609
  • Email: m92beh@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention
Group A: included (42) patients who will receive high protein intake (target: 1.8 g protein/kg body weight /d).
Other: protein diet
this group of patients will receive high protein intake (target: 1.8 g protein/kg BW/d)
Other: Control
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
this group of patients will receive normal protein intake (target: 1.2 g protein/kg BW/d)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitoring muscle mass changes in response to high protein intake
Time Frame: one year
muscle mass using ultrasound and laboratory: titre of CK (Creatinine kinase) level.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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.
Time Frame: one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohammad Esam, Master, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 10, 2023

First Posted (Estimated)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 10, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • protein on muscle mass in ICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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