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Набор скоро начнётся NCT07529522

PRotEin Provision in Critical IllneSs -2

Без фазы С лечением Critical Illness Intensive Care (ICU)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: enteral nutrition, enteral nutrition.
Кому может быть актуально
Состояния в реестре: Critical Illness, Intensive Care (ICU). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия, Нидерланды
Следующий шаг
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Официальное название

The Impact of Low Versus Standard Enteral Protein Provision on Health-related Quality of Life Following Intensive Care Admission: a Randomised Controlled, Multicentre, Parallel Group Trial in Mechanically Ventilated, Critically Ill Patients

Обзор

When patients survive a life-threatening condition in the intensive care unit (ICU), they often face a prolonged recovery process marked by persistent health issues that significantly reduce their quality of life. Muscle weakness is the most defining feature of this post-intensive care syndrome. This weakness, along with the associated decline in quality of life, presents major challenges for patients, their families, and the healthcare system, including the high costs of long-term care. Until recently, it was believed that providing additional nutrition-particularly protein-during the early phase of a critical illness could help prevent muscle loss and promote recovery. However, the recent PRECISe study showed that administering a high amount of protein (target: 2 g/kg per day) via feeding tube actually worsened outcomes: patients who received high-protein nutrition during the acute phase reported a lower quality of life over the six months following ICU admission and were discharged from the hospital later. These findings from the PRECISe study have renewed attention on the amount of protein administered to critically ill patients. Current European ICU nutrition guidelines (1.3 g/kg per day) recommend a higher protein intake than the daily recommended amount for healthy individuals (0.8 g/kg per day). However, in critically ill patients, protein metabolism may be impaired, potentially leading to the accumulation of toxic protein breakdown products and hindering recovery, ultimately resulting in a lower quality of life. Reducing protein intake below the level recommended for healthy individuals during the acute phase of a life-threatening illness-while maintaining total energy intake (calories)-may be beneficial for long-term recovery and rehabilitation. The PRECISe-2 study investigates whether patients who receive less protein (0.6-0.8 g/kg per day) but sufficient energy during the early phase of their critical illness feel better and experience a higher quality of life in the long term compared to those who receive the standard amount of protein (1.3 g/kg per day).

Вмешательства

  • Другое enteral nutrition
    0.6 g protein/kg per day during the first 10 days of enteral nutrition and thereafter 0.8 g protein/kg per day
  • Другое enteral nutrition
    1.3 g protein/kg per day during the entire treatment duration

Первичные конечные точки

  • Overall longitudinal between group difference in Health-Related Quality of Life (HRQL) at 30, 60, and 90 days after index ICU admission assessed by EuroQoL (EQ-5D-5L) [Срок оценки: 30, 60, and 90 days after index ICU admission]

Критерии участия

Критерии включения

  • Adult (≥ 18 years-old) patient
  • Admission to the ICU
  • Invasive, mechanical ventilation initiated within 72 hours following ICU admission, or mechanically ventilated upon arrival to the ICU
  • Expected ICU stay on mechanical ventilation of ≥ 3 days after randomisation

Критерии исключения

  • Expected contra-indication for enteral nutrition for at least one week, at the discretion of the treating physician, such as a bowel discontinuity that cannot be solved within one week
  • Moribund (expected to die within 48 hours) or withholding of treatment (DNR code 3)
  • Previous inclusion in the PRECISe-2 trial
  • Transfer from another ICU with an ICU stay longer than 3 days

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
Тройное слепое
Основная цель
Другое

Центры проведения

Бельгия · 14 центров
  • UZ Antwerpen — Antwerp
  • Ziekenhuis Oost-Limburg — Genk
  • AZ Maria Middelares — Ghent
  • UZ Gent — Ghent
  • Jessa Ziekenhuis — Hasselt
  • UZ Brussel — Jette
  • AZ Groeninge — Kortrijk
  • UZ Leuven — Leuven
  • … и ещё 6 центров
Нидерланды · 1 центр
  • MUMC+ — Maastricht

Идентификаторы

NCT: NCT07529522 · PRECISe-2 (Z-2025138)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗