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临床试验/NCT04633421
NCT04633421已完成不适用

The Impact of High Versus Standard Enteral Protein Provision on Functional Recovery Following Intensive Care Admission: a Randomized Controlled, Multicenter, Parallel Group Trial in Mechanically Ventilated, Critically Ill Patients

Maastricht University Medical Center12 个研究点 分布在 2 个国家目标入组 935 人开始时间: 2020年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
935
试验地点
12
主要终点
Health Related Quality of Life (HRQL)

研究概览

简要总结

Rapid skeletal muscle wasting during critical illness had a detrimental impact on both short and long term outcomes following ICU admission. Increased dietary protein delivery might attenuate skeletal muscle wasting and its subsequent effects on post-ICU function.

The investigators will conduct a 935 patient, randomised controlled, quadruple blinded parallel group trial to determine whether enteral nutrition with increased protein content in mechanically ventilated, critically ill patients is able to improve functional recovery.

详细描述

ICU-acquired weakness (ICU-AW) is frequent among ICU survivors and negatively affects both short and long term outcomes. ICU-AW is the consequence of the body's reserves being depleted during critical illness and results in severe skeletal muscle wasting during the first week of ICU admission.Therefore, measures aimed at preserving muscle mass during critical illness and improving recovery after ICU discharge are urgently needed.

Retrospective observational cohort studies suggest that the administration of high protein nutrition is associated with improved survival and outcome. Current ICU guidelines recommend dietary protein delivery at 1.3 g/kg/day (ESPEN), or even up to 2.0 g/kg/day (ASPEN). However, strong prospective clinical evidence on the effectiveness and safety of high enteral protein delivery is lacking and urgently awaited. Therefore, the aim of the present study is to investigate the effect of high versus standard protein provision on the functional recovery of critically ill patients.

The focus on functional, patient-centered outcomes rather than traditional clinical endpoints like mortality is an important aspect and strength of the study. Previous nutritional intervention studies focusing primarily on improving mortality have repeatedly shown no effect. Therefore, it is nowadays increasingly recognized to move primary ICU trial endpoints away from classical outcomes, such as survival or length of stay, towards more functional outcomes, in line with the underlying pathophysiology.

研究设计

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

盲法说明

Study feeds will be blinded. Dosing of intervention will be volume based, with the same volume targets for both groups. Differences in composition of study feeds will result in differences in protein intake at similar volume administration.

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 or above) patient admitted to the ICU
  • Unplanned ICU admission
  • Invasive mechanical ventilation initiated <24 hours of ICU admission
  • Expected ICU stay on ventilator support of 3 days or more

排除标准

  • Contraindication for enteral nutrition
  • Moribund or expected withholding of treatment
  • Kidney failure AND 'no-dialysis'-code on admission
  • Hepatic encephalopathy.(West Haven grade 3 or 4)
  • Body-mass index < 18 kg/m2

结局指标

主要结局

Health Related Quality of Life (HRQL)

时间窗: Day 0, Day 30, 90 and 180 after index ICU admission.

Overall difference in EQ-5D single summary index between intervention and control group over the three time-points combined, corrected for baseline. A higher summary index indicates better Health related Quality of Life.

次要结局

  • Mental health status - anxiety/depression(Day 30, 90 and 180 after ICU admission)
  • Overall survival(Day 30, 90 and 180 after ICU admission)
  • Physical function - 6-minute walk test(Day 30, 90 and 180 after ICU admission)
  • Self-reported health(Day 0, Day 30, 90 and 180 after index ICU admission)
  • Muscle and nerve function - MRC-sum score(Day 30, 90 and 180 after ICU admission)
  • Muscle and nerve function - handgrip strength(Day 30, 90 and 180 after ICU admission.)
  • Health-related Quality of Life - SF-36(Day 30, 90 and 180 after ICU admission)
  • Mental health status - post-traumatic stress(Day 30, 90 and 180 after ICU admission.)
  • Pain intensity(Day 0, Day 30, 90 and 180 after index ICU admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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