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

NCT07634328 | Active Not Recruiting DMC

• 1 other identifier: M846
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanically Ventilated Patients; Severe Pneumonia

Keywords

high-protein diet; quadriceps ultrasound; severe pneumonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Preservation of Quadriceps Muscle Mass Assessed by Ultrasound

  2 weeks

• Diaphragm Muscle Thickness Assessed by Ultrasound

  2 weeks

• Incidence of ICU-Acquired Weakness

  1 to 4 weeks

• ICU Length of Stay

  2 to 4 weeks

• Mortality

  2 to 4 weeks

Study Arms (2)

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.

Eligibility Criteria

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

Study Population

mechanically ventilated patients with severe pneumonia

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Faculty of medicine Fayoum university

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant of Critical Care Medicine Department

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: October 9, 2025
• Primary Completion (Estimated): September 9, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2025-10

Locations

EG (1)