Impact of a High-Protein Diet on Clinical Outcomes in Mechanically Ventilated Patients With Severe Pneumonia

prospective, comparative, observational study will be conducted at the Critical Care Department, Fayoum University Hospital, to evaluate the impact of a high-protein diet versus a standard-protein diet in mechanically ventilated patients with severe pneumonia.

Study Overview

• Status: Active, not recruiting
• Conditions: Mechanically Ventilated Patients; Severe Pneumonia

Detailed Description

prospective, comparative, observational study will be conducted at the Critical Care Department, Fayoum University Hospital, aims to evaluate the effect of a high-protein diet on clinical outcomes in mechanically ventilated patients with severe pneumonia, focusing on muscle preservation and weaning ability. The specific objectives are:

1. To assess the impact of high-protein intake on skeletal muscle mass using quadriceps ultrasound.
2. To evaluate diaphragmatic function and thickness in relation to protein intake using ultrasound.
3. To determine the effect of high-protein nutrition on weaning success, duration of mechanical ventilation, length of hospital stay and mortality.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Egypt
  • Faiyum Governorate
    • Al Fayyum, Faiyum Governorate, Egypt, 63514
      • Faculty of medicine Fayoum university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

mechanically ventilated patients with severe pneumonia

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Mechanically ventilated patients with severe pneumonia.
• Expected ICU stay ≥ 72 hours.

Exclusion Criteria:

• Patients who died before 72 hours of ICU admission.
• Chronic liver failure or decompensated cirrhosis.
• End-stage renal disease (CKD stage 5 or dialysis dependent).
• Neuromuscular diseases or pre-existing severe muscle wasting.
• Pregnancy.
• Patients with pre-existing malnutrition (e.g., BMI <18.5 kg/m² ).

• Contraindications to enteral feeding, such as:

  1. Mechanical bowel obstruction.
  2. Severe gastrointestinal bleeding.
  3. High-output fistulas involving the gastrointestinal tract.
  4. Recent gastrointestinal surgery preventing enteral access.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
High-protein group; Group of mechanically ventilated patients with severe pneumonia that will receive Protein intake 2.0 g/kg/day.
Standard-protein group; Group of mechanically ventilated patients with severe pneumonia that will receive Protein intake 1.2 g/kg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation	The total time in days during which the patient receives invasive mechanical ventilatory support through an endotracheal tube or tracheostomy, calculated from the initiation of mechanical ventilation until successful liberation from the ventilator or death.	From enrollment to the end of treatment at 1 to 2 weeks
Weaning Success	Successful discontinuation of mechanical ventilatory support with maintenance of spontaneous breathing after extubation, without the need for re-intubation, reinstitution of invasive mechanical ventilation, or death within 48 hours.	1 to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preservation of Quadriceps Muscle Mass Assessed by Ultrasound	Preservation of quadriceps muscle mass was assessed using bedside ultrasonography by measuring the quadriceps muscle thickness at predefined anatomical landmarks. Muscle preservation was defined as the percentage change in muscle thickness from baseline to the follow-up assessment, with a smaller reduction indicating better preservation of muscle mass.	2 weeks
Diaphragm Muscle Thickness Assessed by Ultrasound	Diaphragm muscle thickness was assessed using bedside ultrasonography in the zone of apposition of the diaphragm. The thickness of the diaphragm measured by ultrasound at the zone of apposition, expressed in millimeters (mm). Measurements were obtained at end-expiration, and the percentage change from baseline was used to assess diaphragm muscle preservation or atrophy. Diaphragm Thickening Fraction (DTF) (%)=(DT at end-inspiration - DT at end-expiration) ÷ DT at end-expiration × 100. TF ≥ 20% is considered normal; < 20% suggests diaphragmatic dysfunction.	2 weeks
Incidence of ICU-Acquired Weakness	The percentage of patients who develop ICU-acquired weakness during ICU admission. ICU-AW was diagnosed when the MRC sum score was <48/60 during ICU admission.	1 to 4 weeks
ICU Length of Stay	The number of days spent in the ICU, calculated from ICU admission to ICU discharge, transfer to another ward, or death during ICU stay.	2 to 4 weeks
Mortality	The proportion of patients who die during their ICU stay, calculated from ICU admission until ICU discharge.	2 to 4 weeks

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2025
• Primary Completion (Estimated): September 9, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: severe pneumonia; high-protein diet; quadriceps ultrasound
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: M846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No