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Trials and the importance of usual care
Critical Care ( IF 8.8 ) Pub Date : 2024-07-08 , DOI: 10.1186/s13054-024-04977-1
Kyle C White _{1,

2,

3,

4} , Kevin B Laupland _{3,

5} , Rinaldo Bellomo _{6,

7,

8,

9} ,

Affiliation

Dear Editor,

We read with great interest the REDUSE trial paper by Linden and colleagues [1] and particularly commend the comprehensive protocol that recognised the importance of nutrition to fluid accumulation [2] and detailed instructions on concentrating drug administration.

However, we are concerned about the external validity of fluid input with the usual care arm of the REDUSE trial. Such patients received a median fluid input of 9.76 L in the first three days of ICU stay.

In 6412 patients with septic shock, from a previously described cohort [3], admitted to 12 participating ICUs in Australia we found a median fluid input over the first 3 days, D0–D3, of 5.99 L. The overall fluid input over the first three days of ICU admission, together with the single-day breakdown is presented in Fig. 1. The median fluid input of under 6 L was the same as the 6.01 L reported in the intervention arm of the REDUSE trial, demonstrating different baseline practices.

Furthermore, recent evidence in renal replacement therapy has demonstrated profound geographical variation in fluid management practices [4]. The assumption that the results of the trial can applied to different jurisdictions may be inaccurate and could have consequences on future, multinational interventional trials, and, ultimately, patient care.

Second, we would like to stress that the REDUSE trial intervention did not highlight the impact on fluid balance, as this information is relegated to the supplemental material. Recent work in critically ill patients with acute kidney injury has demonstrated the importance of urine output and diuretic therapy to the multi-factor development of fluid accumulation [2]. In the REDUSE trial cumulative fluid balance at day 3 was + 2317 mL in the usual care arm, whereas, in our cohort of > 6000 patients, the median cumulative FB was + 544 mL, D0–D3.

We believe that addressing these concerns will contribute to a more comprehensive understanding of fluid management in critically ill patients and guide future research in this important area.

Lindén A, Spångfors M, Olsen MH, Fisher J, Lilja G, Sjövall F, et al. Protocolized reduction of non-resuscitation fluids versus usual care in septic shock patients (REDUSE): a randomized multicentre feasibility trial. Crit care (Lond, Engl). 2024;28(1):166.
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White KC, Serpa-Neto A, Hurford R, Clement P, Laupland KB, Ostermann M, et al. How a positive fluid balance develops in acute kidney injury: A binational, observational study. J Crit Care. 2024;82:154809.
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White KC, Serpa-Neto A, Hurford R, Clement P, Laupland KB, See E, et al. Sepsis-associated acute kidney injury in the intensive care unit: incidence, patient characteristics, timing, trajectory, treatment, and associated outcomes. A multicenter, observational study. Intensiv Care Med. 2023;49:1–11.
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Vaara ST, Neto AS, Bellomo R, Adhikari NKJ, Dreyfuss D, Gallagher M, et al. Regional practice variation and outcomes in the standard versus accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI) trial: a post hoc secondary analysis. Crit Care Explor. 2024;6(2):e1053.
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This research received no specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Authors and Affiliations

Intensive Care Unit, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Brisbane, QLD, 4102, Australia
Kyle C. White
Intensive Care Unit, Queen Elizabeth II Jubilee Hospital, Coopers Plains, QLD, Australia
Kyle C. White
Faculty of Health, School of Clinical Sciences, Queensland University of Technology, Brisbane, QLD, Australia
Kyle C. White & Kevin B. Laupland
Mayne Academy of Critical Care, Faculty of Medicine, University of Queensland, St Lucia, QLD, Australia
Kyle C. White
Intensive Care Services, Royal Brisbane and Women’s Hospital, Herston, QLD, Australia
Kevin B. Laupland
Department of Intensive Care, Austin Hospital, Heidelberg, VIC, Australia
Rinaldo Bellomo
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia
Rinaldo Bellomo
Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia
Rinaldo Bellomo
Department of Intensive Care, Royal Melbourne Hospital, Melbourne, VIC, Australia
Rinaldo Bellomo

Authors

Kyle C. WhiteView author publications
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Kevin B. LauplandView author publications
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Rinaldo BellomoView author publications
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Consortia

Queensland Critical Care Research Network (QCCRN)

Contributions

All authors (KW, KL, and RB) were involved in the concept, drafting, and review of final version.

Corresponding author

Correspondence to Kyle C. White.

Ethics approval and consent to participate

The data presented in this correspondence was approved by the Metro South Hospital and Health Service Human Research Ethics Committee (HREC/2022/QMS/82024) with an individual waiver of consent granted.

Competing interests

The authors declare no competing interests.

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White, K.C., Laupland, K.B., Bellomo, R. et al. Trials and the importance of usual care. Crit Care 28, 223 (2024). https://doi.org/10.1186/s13054-024-04977-1

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Received: 27 May 2024
Accepted: 31 May 2024
Published: 08 July 2024
DOI: https://doi.org/10.1186/s13054-024-04977-1

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中文翻译：

试验和日常护理的重要性

亲爱的编辑，

我们饶有兴趣地阅读了 Linden 及其同事的 REDUSE 试验论文 [1]，并特别赞扬了该综合方案，该方案认识到营养对液体蓄积的重要性 [2] 以及集中给药的详细说明。

然而，我们担心 REDUSE 试验的常规护理组液体输入的外部有效性。这些患者在入住 ICU 的前三天接受的中位液体输入量为 9.76 L。

在来自先前描述的队列 [3] 的 6412 名感染性休克患者中，入住澳大利亚 12 个参与的 ICU，我们发现前 3 天（D0-D3）的中位液体输入量为 5.99 L。第一天的总体液体输入量图 1 显示了入住 ICU 三天的情况以及单日细目。中位液体输入量低于 6 L，与 REDUSE 试验干预组报告的 6.01 L 相同，表明了不同的基线实践。

此外，肾脏替代治疗的最新证据表明液体管理实践存在巨大的地理差异[4]。试验结果可以适用于不同司法管辖区的假设可能不准确，并且可能对未来的多国介入试验以及最终的患者护理产生影响。

其次，我们要强调的是，REDUSE 试验干预并未强调对液体平衡的影响，因为该信息已归入补充材料。最近对患有急性肾损伤的危重患者的研究表明，尿量和利尿治疗对液体蓄积的多因素发展的重要性[2]。在 REDUSE 试验中，常规护理组第 3 天的累积液体平衡为 + 2317 mL，而在我们超过 6000 名患者的队列中，中位累积 FB 为 + 544 mL（D0-D3）。

我们相信，解决这些问题将有助于更全面地了解危重患者的液体管理，并指导这一重要领域的未来研究。

Lindén A、Spångfors M、Olsen MH、Fisher J、Lilja G、Sjövall F 等。脓毒性休克患者的非复苏液体减少与常规护理相比的方案减少（REDUSE）：一项随机多中心可行性试验。重症监护（伦敦，英格兰）。 2024；28(1):166。
文章谷歌学术
White KC、Serpa-Neto A、Hurford R、Clement P、Laupland KB、Ostermann M 等。急性肾损伤中液体正平衡如何发展：一项两国观察性研究。 J 重症监护。 2024；82：154809。

文章 PubMed 谷歌学术
White KC、Serpa-Neto A、Hurford R、Clement P、Laupland KB、See E 等人。重症监护病房中脓毒症相关的急性肾损伤：发病率、患者特征、时间、轨迹、治疗和相关结果。一项多中心观察性研究。重症监护医学。 2023；49：1–11。
文章谷歌学术
Vaara ST、Neto AS、Bellomo R、Adhikari NKJ、Dreyfuss D、Gallagher M 等。急性肾损伤标准肾脏替代治疗与加速启动肾脏替代治疗 (STARRT-AKI) 试验的区域实践差异和结果：事后二次分析。急救护理探索。 2024；6(2)：e1053。

文章 PubMed PubMed Central Google Scholar

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作者和单位

亚历山德拉公主医院重症监护室, 199 Ipswich Road, Woolloongabba, 布里斯班, QLD, 4102, 澳大利亚
凯尔·C·怀特
澳大利亚昆士兰州库珀斯普莱恩斯伊丽莎白二世女王朱比利医院重症监护室
凯尔·C·怀特
昆士兰科技大学临床科学学院健康学院，澳大利亚昆士兰州布里斯班

凯尔·C·怀特 (Kyle C. White) 和凯文·B·劳普兰 (Kevin B. Laupland)
昆士兰大学医学院梅恩重症监护学院，澳大利亚昆士兰州圣卢西亚
凯尔·C·怀特
澳大利亚昆士兰州赫斯顿皇家布里斯班妇女医院重症监护服务
凯文·B·劳普兰
澳大利亚维多利亚州海德堡奥斯汀医院重症监护室
里纳尔多·贝洛莫
澳大利亚和新西兰重症监护研究中心 (ANZIC-RC)，莫纳什大学公共卫生和预防医学学院，澳大利亚维多利亚州墨尔本
里纳尔多·贝洛莫
墨尔本大学重症监护系，澳大利亚维多利亚州墨尔本
里纳尔多·贝洛莫
澳大利亚维多利亚州墨尔本皇家墨尔本医院重症监护室
里纳尔多·贝洛莫

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财团

昆士兰重症监护研究网络 (QCCRN)

贡献

所有作者（KW、KL 和 RB）都参与了最终版本的概念、起草和审查。

通讯作者

通讯作者：凯尔·C·怀特。

道德批准并同意参与

本信件中提供的数据得到了 Metro South 医院和卫生服务人类研究伦理委员会 (HREC/2022/QMS/82024) 的批准，并授予个人放弃同意书。

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