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NCT Number: NCT07634328

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.

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Key information

Conditions

Mechanically Ventilated Patients Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Severe Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine Fayoum university

Al Fayyum, Faiyum Governorate, 63514, Egypt

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Mechanical bowel obstruction.
  • Severe gastrointestinal bleeding.
  • High-output fistulas involving the gastrointestinal tract.
  • Recent gastrointestinal surgery preventing enteral access.

Treatment and study plan

Primary outcomes

  1. Duration of mechanical ventilation

    Time frame: From enrollment to the end of treatment at 1 to 2 weeks

    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.

  2. Weaning Success

    Time frame: 1 to 2 weeks

    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.

Secondary outcomes

  1. Preservation of Quadriceps Muscle Mass Assessed by Ultrasound

    Time frame: 2 weeks

    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. Diaphragm Muscle Thickness Assessed by Ultrasound

    Time frame: 2 weeks

    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.

  3. Incidence of ICU-Acquired Weakness

    Time frame: 1 to 4 weeks

    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.

  4. ICU Length of Stay

    Time frame: 2 to 4 weeks

    The number of days spent in the ICU, calculated from ICU admission to ICU discharge, transfer to another ward, or death during ICU stay.

  5. Mortality

    Time frame: 2 to 4 weeks

    The proportion of patients who die during their ICU stay, calculated from ICU admission until ICU discharge.

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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