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

N/AActive Not RecruitingNCT07634328

Fayoum University60 enrolled

Overview

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.

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

Conditions

Mechanically Ventilated Patients Severe Pneumonia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of medicine Fayoum university

Al Fayyum, Faiyum Governorate, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 to 2 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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