Impact of a High-Protein Diet on Clinical Outcomes in Mechanically Ventilated Patients With Severe Pneumonia
3 juni 2026 uppdaterad av: Mahmoud Abdelnabi Abdelhalim Ahmed, Fayoum University
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.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
60
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Faiyum Governorate
-
Al Fayyum, Faiyum Governorate, Egypten, 63514
- Faculty of medicine Fayoum university
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
mechanically ventilated patients with severe pneumonia
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Duration of mechanical ventilation
Tidsram: 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.
|
From enrollment to the end of treatment at 1 to 2 weeks
|
|
Weaning Success
Tidsram: 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.
|
1 to 2 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Preservation of Quadriceps Muscle Mass Assessed by Ultrasound
Tidsram: 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 weeks
|
|
Diaphragm Muscle Thickness Assessed by Ultrasound
Tidsram: 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. |
2 weeks
|
|
Incidence of ICU-Acquired Weakness
Tidsram: 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.
|
1 to 4 weeks
|
|
ICU Length of Stay
Tidsram: 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.
|
2 to 4 weeks
|
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Mortality
Tidsram: 2 to 4 weeks
|
The proportion of patients who die during their ICU stay, calculated from ICU admission until ICU discharge.
|
2 to 4 weeks
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
9 oktober 2025
Primärt slutförande (Beräknad)
9 september 2026
Avslutad studie (Beräknad)
1 oktober 2026
Studieregistreringsdatum
Först inskickad
3 juni 2026
Först inskickad som uppfyllde QC-kriterierna
3 juni 2026
Första postat (Faktisk)
8 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 juni 2026
Senast verifierad
1 oktober 2025
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- M846
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