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

3. juni 2026 oppdatert 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

60

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

mechanically ventilated patients with severe pneumonia

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Duration of mechanical ventilation
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Preservation of Quadriceps Muscle Mass Assessed by Ultrasound
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Mortality
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fayoum University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. oktober 2025

Primær fullføring (Antatt)

9. september 2026

Studiet fullført (Antatt)

1. oktober 2026

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juni 2026

Sist bekreftet

1. oktober 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • M846

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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