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临床试验/NCT07529522
NCT07529522尚未招募不适用

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

Ziekenhuis Oost-Limburg14 个研究点 分布在 2 个国家目标入组 1,026 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,026
试验地点
14
主要终点
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)

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Low protein enteral feeding formula

Experimental

干预措施: enteral nutrition (Other)

Standard protein enteral feeding formula

Active Comparator

干预措施: enteral nutrition (Other)

结局指标

主要结局

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)

时间窗: 30, 60, and 90 days after index ICU admission

overall longitudinal between group-difference in Health-Related Quality of Life (HRQL) at 30, 60, and 90 days after index ICU admission corrected for the pre-admission EQ-5D-5L summary index, assessed by EuroQoL (EQ-5D-5L)

时间窗: 30, 60, and 90 days after index ICU admission

次要结局

未报告次要终点

研究者

发起方
Ziekenhuis Oost-Limburg
申办方类型
Other
责任方
Sponsor

研究点 (14)

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