The effect of early intravenous amino acid supplementation in critically ill patients without acute kidney injury: Protocol for a multicentre, randomised, parallel-controlled trial (the ESSENTIAL trial)

IF 1.4 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation Pub Date : 2024-12-01 DOI:10.1016/j.ccrj.2024.10.002

Lingliang Zhou MD , Gordon S. Doig PhD , Cheng Lv PhD , Lu Ke PhD , Weiqin Li PhD , for the Chinese Critical Care Nutrition Trials Group (CCCNTG)

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引用次数: 0

Abstract

Objective

There is uncertainty about whether early infusion of intravenous amino acids confers clinical benefits in critically ill patients. In this study, we aimed to test the hypothesis that intravenous amino acids could improve 90-day mortality in critically ill patients with normal kidney function.

Design

This is a multicentre, open-label, randomised, parallel-controlled trial.

Setting

20 ICUs across China.

Participants

1928 eligible critically ill patients with normal kidney function.

Interventions

In addition to standard care, patients assigned to the intervention group will receive a continuous infusion of amino acids at a rate to achieve a total daily protein intake of approximately 2.0 g/kg/day.

Main outcome measures

The primary endpoint is all-cause mortality at day 90 after randomisation. Secondary endpoints and process measures will also be reported. The primary conclusions will be based on a modified intention-to-treat analysis for efficacy.

Ethics and dissemination

This study was approved by the ethics committee of the Jinling Hospital, Nanjing University (2020-NZKY-014-02 for the original version and 2020-NZKY-014-06 for the revised version) and all the participating sites. Results will be disseminated through journal publications and conference presentations.

Registration

This study protocol was registered with the Chinese Clinical Trial Registry, and the identifier is ChiCTR2100053359 (https://www.chictr.org.cn/hvshowprojectEN.html?id=257327&v=1.7).

查看原文本刊更多论文

早期静脉补充氨基酸对无急性肾损伤危重患者的影响：多中心、随机、平行对照试验方案（ESSENTIAL试验）

目的：对危重患者早期静脉输注氨基酸是否有临床获益尚不确定。在这项研究中，我们旨在验证静脉注射氨基酸可以改善肾功能正常的危重患者90天死亡率的假设。设计：这是一项多中心、开放标签、随机、平行对照的试验。设置：全国20个icu。参与者：1928例符合条件的肾功能正常的危重患者。干预措施：除标准护理外，被分配到干预组的患者将接受氨基酸的持续输注，以达到每日总蛋白质摄入量约为2.0 g/kg/天。主要结局指标：主要终点是随机分组后第90天的全因死亡率。次要端点和过程度量也将被报告。主要结论将基于对疗效的改良意向治疗分析。伦理与传播：本研究经南京大学金陵医院伦理委员会（原版本为2020-NZKY-014-02，修订版本为2020-NZKY-014-06）和所有参与站点批准。研究结果将通过期刊出版物和会议报告进行传播。注册：本研究方案已在中国临床试验注册中心注册，编号为ChiCTR2100053359 （https://www.chictr.org.cn/hvshowprojectEN.html?id=257327&v=1.7）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Critical Care and Resuscitation CRITICAL CARE MEDICINE-

CiteScore

7.70

自引率

3.40%

发文量

审稿时长

>12 weeks

期刊介绍： ritical Care and Resuscitation (CC&R) is the official scientific journal of the College of Intensive Care Medicine (CICM). The Journal is a quarterly publication (ISSN 1441-2772) with original articles of scientific and clinical interest in the specialities of Critical Care, Intensive Care, Anaesthesia, Emergency Medicine and related disciplines. The Journal is received by all Fellows and trainees, along with an increasing number of subscribers from around the world. The CC&R Journal currently has an impact factor of 3.3, placing it in 8th position in world critical care journals and in first position in the world outside the USA and Europe.