Impact of a High-Protein Diet on Clinical Outcomes in Mechanically Ventilated Patients With Severe Pneumonia
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Faiyum Governorate
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Al Fayyum, Faiyum Governorate, 이집트, 63514
- Faculty of medicine Fayoum university
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
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디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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Standard-protein group
Group of mechanically ventilated patients with severe pneumonia that will receive Protein intake 1.2 g/kg/day.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Duration of mechanical ventilation
기간: From enrollment to the end of treatment at 1 to 2 weeks
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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.
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From enrollment to the end of treatment at 1 to 2 weeks
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Weaning Success
기간: 1 to 2 weeks
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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.
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1 to 2 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Preservation of Quadriceps Muscle Mass Assessed by Ultrasound
기간: 2 weeks
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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.
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2 weeks
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Diaphragm Muscle Thickness Assessed by Ultrasound
기간: 2 weeks
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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
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Incidence of ICU-Acquired Weakness
기간: 1 to 4 weeks
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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.
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1 to 4 weeks
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ICU Length of Stay
기간: 2 to 4 weeks
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The number of days spent in the ICU, calculated from ICU admission to ICU discharge, transfer to another ward, or death during ICU stay.
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2 to 4 weeks
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Mortality
기간: 2 to 4 weeks
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The proportion of patients who die during their ICU stay, calculated from ICU admission until ICU discharge.
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2 to 4 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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