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临床试验/NCT05124860
NCT05124860已完成不适用

A Longitudinal Investigation of Energy Expenditure and Substrate Utilization in Critically Ill Patients: a Prospective Observational Multi-center Study

Karolinska University Hospital7 个研究点 分布在 4 个国家目标入组 714 人开始时间: 2022年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
714
试验地点
7
主要终点
Change in resting energy expenditure over time in patients who stay in ICU for >10 days.

研究概览

简要总结

The metabolic alterations associated with critical illness have significant implications for the nutritional management of ICU patients. Despite this, little is known about these changes in patients requiring prolonged organ support and nutritional therapy.

The overall aim of this study is to describe changes in metabolism over time in a large prospective cohort of patients requiring >10 days of ICU care. Our hypothesis is that there is a significant change in mean energy expenditure and respiratory quotient (RQ) between the early (day 1-3), intermediate (day 4-10) and late (>10 days) phase in ICU.

详细描述

Background

Critical illness has profound effects on human metabolism. The most prominent feature in the early phase is an upregulation of catabolic pathways, which promotes the production of endogenous energy substrates and net protein breakdown [1].

There is very little published data describing trends of energy expenditure and substrate utilization in patients with a prolonged ICU stay. While this group only constitutes a small fraction of ICU patients, it accounts for a large part of ICU resource allocation, morbidity and mortality [2]. Several studies have been conducted in recent years to better characterize patients with persistent critical illness, focusing on markers of catabolism and inflammation [3, 4]. It is not known if these changes are associated with alterations in energy metabolism and substrate utilization.

Bridging these knowledge gaps will improve our understanding of the nutritional needs and metabolism of patients beyond the early phase in ICU. We therefore plan to conduct a prospective observational multi-center study to address these questions.

Aim and hypothesis

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • >/= 18 years old.
  • Admitted to the ICU of a participating study site.
  • At least one measurement of energy expenditure performed during ICU stay.

排除标准

  • Patients readmitted to the ICU of a participating study site >72 hours after ICU discharge and already included in the study (≥1 measurement of energy expenditure performed during prior admission). If a patient is readmitted within ≤72 hours of ICU discharge this is considered a continuation of the last ICU admission for the purposes of this study.
  • Burns >20% of body surface area.

结局指标

主要结局

Change in resting energy expenditure over time in patients who stay in ICU for >10 days.

时间窗: From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.

Kcal/kg adjusted body weight/24 hours.

次要结局

  • Change in respiratory quotient over time in patients who stay in ICU for ≤10 days.(From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.)
  • Change in respiratory quotient over time in patients who stay in ICU for >10 days.(From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.)
  • Change in resting energy expenditure (kcal/kg/day) over time in patients who stay in ICU for ≤10 days.(From date of ICU admission to the date of ICU discharge or death, whichever came first, assessed up to 24 months.)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Sundstrom Rehal

Principal Investigator

Karolinska University Hospital

研究点 (7)

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