Study protocol and statistical plan for the ICRAKI trial: Intermittent haemodialysis versus continuous renal replacement therapy for severe acute kidney injury in critically ill patients

IF 1.4 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation Pub Date : 2025-05-06 DOI:10.1016/j.ccrj.2025.100107

Stéphane Gaudry MD, PhD , Marouane Boubaya MD , Guillaume Louis MD , Khalil Chaïbi MD, PhD , Bruno Mégarbane MD, PhD , Julien Bohe MD, PhD , Maxime Desgrouas MD , Guillaume Gele-Decaudin MD , Adrien Joseph MD, PhD , Etienne de Montmollin MD, PhD , Christophe Camus MD, PhD , Nicolas De Prost MD, PhD , Pierre Bailly MD , Samir Jaber MD, PhD , Nicolas Chudeau MD , Alexis Lambour MD , Adrien Robine MD , Béatrice La Combe MD, PhD , Antoine Kimmoun MD, PhD , Guillaume Chevrel MD , Didier Dreyfuss MD

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引用次数: 0

Abstract

Background

The effect of intermittent haemodialysis (IHD) vs continuous renal replacement therapy (CRRT) on mortality and/or renal function recovery in adults with acute kidney injury (AKI) and a recognised indication for renal replacement therapy (RRT) remains controversial.

Objective

To summarise the protocol and statistical analysis plan for the ICRAKI trial.

Design, settings and participants

ICRAKI is a non-inferiority multicentre randomised controlled trial comparing IHD and CRRT. We will include 1000 patients with AKI receiving (or who have received) invasive mechanical ventilation and/or catecholamine infusion and who have at least one recognised criterion for initiating RRT.

Intervention

The study compares IHD with CRRT.

Main outcomes measures

The primary endpoint is the proportion of patients who will meet one or more criteria for a major adverse kidney event (composite of death, RRT dependence and/or more than a 25 % increase in serum creatinine from baseline value) 90 days after randomisation. Secondary endpoints are time to death; mortality at day (D)28, D60 and D90; number of patients with RRT dependency at D28, D60 and D90; number of patients with more than a 25 % increase in serum creatinine from baseline value at D28, D60 and D90; intensive care unit (ICU) and hospital length of stay; time until cessation of RRT; catecholamine-free days, ventilator-free days and RRT-free days through day 28; estimated glomerular filtration rate at hospital discharge; the number of episodes of adverse events.

Conclusion

The ICRAKI trial will inform the choice of RRT modalities in critically ill patients with severe AKI. More than 300 patients were already included.

Trial registration

ClinicalTrials.gov: NCT06032884. Date of registration, 2023-09-04.

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ICRAKI试验的研究方案和统计计划：间歇血液透析与持续肾脏替代疗法治疗危重患者严重急性肾损伤

背景：间歇性血液透析（IHD）与持续肾替代治疗（CRRT）对急性肾损伤（AKI）成人患者死亡率和/或肾功能恢复的影响以及肾替代治疗（RRT）的公认适应症仍存在争议。目的总结ICRAKI试验的方案和统计分析方案。raki是一项比较IHD和CRRT的非劣效性多中心随机对照试验。我们将纳入1000名接受（或已经接受）有创机械通气和/或儿茶酚胺输注的AKI患者，这些患者至少有一个公认的启动RRT的标准。该研究比较了IHD和CRRT。主要结局指标：主要终点是随机分组后90天满足一个或多个主要肾脏不良事件（死亡、RRT依赖和/或血清肌酐较基线值增加25%以上）标准的患者比例。次要终点是死亡时间；第28天、第60天和第90天死亡率；D28、D60、D90时RRT依赖患者数量；在D28、D60和D90时血清肌酐较基线值增加超过25%的患者人数；重症监护病房（ICU）和住院时间；直至RRT停止的时间；无儿茶酚胺天数、无呼吸机天数和无rrt天数；估计出院时肾小球滤过率；不良事件的发作次数。ICRAKI试验将为重症AKI患者的RRT模式选择提供信息。已有300多名患者被纳入研究。临床试验注册：NCT06032884。注册日期：2023-09-04。

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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.