Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis

Официальное название

Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis: a Single-Center, Prospective, Randomized Controlled Study

Обзор

To explore the effects of early enteral nutrition with short peptide formula on energy metabolism and clinical outcomes in patients with sepsis based on blood samples, clinical database, full-spectrum metabolomics test and imaging data, and to form a theoretical basis for optimizing the formula of early enteral nutrition in patients with sepsis.

Подробное описание

This study is a single-center prospective trial. Based on the annual patient volume, available human resources, and funding at our research center, the expert team determined a sample size of 80 cases, with 40 cases in the experimental group and 40 in the control group. Eligible participants will be randomized 1:1 via computer-generated randomization into two groups, receiving either a short-peptide-based enteral nutrition formula or a whole-protein-based enteral nutrition formula.

Short-peptide formula group:

Within 48 hours of ICU admission, short-peptide-based enteral nutrition (Peptisorb) will be initiated. For patients with impaired swallowing or unconsciousness, a nasogastric tube will be placed. Feeding will start with low-calorie or trophic feeding, reaching 70% of the target energy and 1.2-1.5 g/kg/day of protein within 7 days. Due to significant individual variability in energy expenditure among sepsis patients, indirect calorimetry (IC) will be used to measure energy needs. If IC is unavailable, a weight-based formula (20-25 kcal/kg/day) will be applied. If patients remain in the ICU after 7 days, feeding will be gradually increased to full energy and protein targets as tolerated, followed by a transition to whole-protein nutrition.

Whole-protein formula group:

Within 48 hours of ICU admission, whole-protein-based enteral nutrition (Nutrison) will be initiated, with the remaining protocol identical to the short-peptide group.

The study will assess changes in metabolomics after 7 days of early enteral nutrition with different protein formulations in sepsis patients, as well as differences in nutritional status, biochemical markers, and short- and long-term clinical outcomes.

Вмешательства

• Пищевая добавка Short peptide enteral nutrition
  Short peptide formula enteral nutrition was initiated within 48 hours after admission to the ICU. For patients with poor swallowing function or no consciousness, nasogastric tubes were placed. Starting from low-calorie or nourishing feeding, 70% of the target energy should be achieved within 7 days, and the protein should be 1.2-1.5 g/kg/d. Due to the large individual differences in energy expenditure among patients with sepsis, the indirect calorimetry (IC) method was used to determine energy e
• Пищевая добавка Whole protein enteral nutrition
  The whole protein formula enteral nutrition was initiated within 48 hours of admission to the ICU, and the rest were same.

Первичные конечные точки

• Metabolomics changes form [Срок оценки: On the 7th day after enrollment]

Вторичные конечные точки (12)

• Daily average protein intake [Срок оценки: 7 days]
• Daily average energy intake [Срок оценки: 7 days]
• Energy adequacy rate [Срок оценки: On the 3rd and 7th day after enrollment]
• Inflammatory markers [Срок оценки: 7 days]
• Nutritional status [Срок оценки: 7 days]
• Liver function [Срок оценки: 7 days]
• Renal function [Срок оценки: 7 days]
• Enteral nutritional tolerance rate [Срок оценки: 7 days]
• Skeletal muscle depletion condition [Срок оценки: 7 days]
• Days of ventilator use [Срок оценки: 28 days]
• 28-day all-cause mortality rate [Срок оценки: 28 days]
• All-cause mortality at 90 days [Срок оценки: 90 days]

Критерии участия

Критерии включения

• Informed consent has been signed
• Aged from 18 to 80 years old
• Within 24 hours after admission to ICU
• Sepsis was diagnosed according to the 2016 International Sepsis 3.0 diagnostic criteria
• Without gastrointestinal perforation, bleeding, obstruction and other contraindications to enteral nutrition
• Expected ICU stay for more than 7 days

Критерии исключения

• Receiving palliative care or expected to die within 72 hours
• Pregnant or breastfeeding
• Use of high dose vasopressor maintenance (norepinephrine dosage > 0.5 μg/kg/min)
• Requiring restricted protein intake or additional protein supplementation (e.g., patients with hepatic encephalopathy, severe renal insufficiency, severe burns, severe malnutrition, etc..)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07038057 · B2025-213R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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