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针对危重症患者在住院期间提供定制营养干预对每日能量供应的影响(INTENT):一项II期随机对照试验。

The impact of a tailored nutrition intervention delivered for the duration of hospitalisation on daily energy delivery for patients with critical illness (INTENT): a phase II randomised controlled trial.

作者信息

Ridley Emma J, Bailey Michael, Chapman Marianne J, Chapple Lee-Anne S, Deane Adam M, Gojanovic Marlene, Higgins Alisa M, Hodgson Carol L, King Victoria L, Marshall Andrea P, Miller Eliza G, McGuinness Shay P, Parke Rachael L, Paul Eldho, Udy Andrew A

机构信息

Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Department of Epidemiology and Preventative Medicine, Monash University, 553 St Kilda Road, Melbourne, VIC, Australia.

Nutrition Department, The Alfred Hospital, Melbourne, VIC, Australia.

出版信息

Crit Care. 2025 Jan 6;29(1):8. doi: 10.1186/s13054-024-05189-3.

DOI:10.1186/s13054-024-05189-3
PMID:39762887
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11706088/
Abstract

BACKGROUND

Nutrition interventions commenced in ICU and continued through to hospital discharge have not been definitively tested in critical care to date. To commence a program of research, we aimed to determine if a tailored nutrition intervention delivered for the duration of hospitalisation delivers more energy than usual care to patients initially admitted to the Intensive Care Unit (ICU).

METHODS

A multicentre, unblinded, parallel-group, phase II trial was conducted in twenty-two hospitals in Australia and New Zealand. Adult patients, requiring invasive mechanical ventilation (MV) for 72-120 h within ICU, and receiving < 80% estimated energy requirements from enteral nutrition (EN) were included. The intervention (tailored nutrition) commenced in ICU and included EN and supplemental parenteral nutrition (PN), and EN, PN, and/or oral nutrition after liberation from MV, and was continued until hospital discharge or study day 28. The primary outcome was daily energy delivery from nutrition (kcal). Secondary outcomes included duration of hospital stay, ventilator free days at day 28 and total blood stream infection rate.

MAIN RESULTS

The modified intention to treat analysis included 237 patients (n = 119 intervention and n = 118 usual care). Baseline characteristics were balanced; the median [interquartile range] intervention period was 19 [14-35] and 19 [13-32] days in the tailored nutrition and usual care groups respectively. Energy delivery was 1796 ± 31 kcal/day (tailored nutrition) versus 1482 ± 32 kcal/day (usual care)-adjusted mean difference 271 kcal/day, 95% CI 189-354 kcal. No differences were observed in any secondary outcomes.

CONCLUSIONS

A tailored nutrition intervention commenced in the ICU and continued until hospital discharge achieved a significant increase in energy delivery over the duration of hospitalisation for patients initially admitted to the ICU. Trial registration ClinicalTrials.gov Identifier NCT03292237 . First registered 25th September 2017. Last updated 10th Feb 2023.

摘要

背景

迄今为止,在重症监护中,始于重症监护病房(ICU)并持续至出院的营养干预措施尚未得到最终验证。为启动一项研究计划,我们旨在确定在住院期间提供的定制营养干预措施是否比常规护理为最初入住重症监护病房(ICU)的患者提供更多能量。

方法

在澳大利亚和新西兰的22家医院进行了一项多中心、非盲、平行组、II期试验。纳入在ICU内需要有创机械通气(MV)72 - 120小时且肠内营养(EN)提供的能量需求估计值低于80%的成年患者。干预措施(定制营养)始于ICU,包括EN和补充性肠外营养(PN),在脱离MV后包括EN、PN和/或口服营养,并持续至出院或研究第28天。主要结局是营养提供的每日能量(千卡)。次要结局包括住院时间、第28天无呼吸机天数和总血流感染率。

主要结果

改良意向性分析纳入237例患者(n = 119例干预组和n = 118例常规护理组)。基线特征均衡;定制营养组和常规护理组的干预期中位数[四分位间距]分别为19[14 - 35]天和19[13 - 32]天。能量提供量为1796±31千卡/天(定制营养组)对1482±32千卡/天(常规护理组)——调整后平均差异为271千卡/天,95%置信区间为189 - 354千卡。在任何次要结局中均未观察到差异。

结论

始于ICU并持续至出院的定制营养干预措施,在最初入住ICU的患者住院期间显著增加了能量提供量。试验注册ClinicalTrials.gov标识符NCT03292237。首次注册于2017年9月25日。最后更新于2023年2月10日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c10/11706088/faddb0391d75/13054_2024_5189_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c10/11706088/da1fc3e78d10/13054_2024_5189_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c10/11706088/59684430d07c/13054_2024_5189_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c10/11706088/faddb0391d75/13054_2024_5189_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c10/11706088/da1fc3e78d10/13054_2024_5189_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c10/11706088/59684430d07c/13054_2024_5189_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c10/11706088/faddb0391d75/13054_2024_5189_Fig3_HTML.jpg

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