Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 May 6;27(2):100107.
doi: 10.1016/j.ccrj.2025.100107. eCollection 2025 Jun.

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

Stéphane Gaudry  1   2   3   4 , Marouane Boubaya  5 , Guillaume Louis  6 , Khalil Chaïbi  1   2 , Bruno Mégarbane  7 , Julien Bohe  8 , Maxime Desgrouas  9 , Guillaume Gele-Decaudin  10 , Adrien Joseph  11 , Etienne de Montmollin  12 , Christophe Camus  13 , Nicolas De Prost  14 , Pierre Bailly  15 , Samir Jaber  16 , Nicolas Chudeau  17 , Alexis Lambour  18 , Adrien Robine  19 , Béatrice La Combe  20 , Antoine Kimmoun  21 , Guillaume Chevrel  22 , Laurent Argaud  23 , Jonathan Nicolas  24 , Guillaume Thiery  25 , Stanislas Faguer  26 , Mathieu Jozwiak  27 , Jean-Damien Ricard  28 , Damien Contou  29 , Mehdi Marzouk  30 , Benjamin Chousterman  31   32 , Julien Cadiet  33 , Côme Bureau  34 , Isabelle Durand Zaleski  35 , Patrick Rossignol  36   37 , Jean-Pierre Quenot  38 , Coralie Bloch Queyrat  39 , Didier Dreyfuss  2   40
Affiliations

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

Stéphane Gaudry et al. Crit Care Resusc. .

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.

Keywords: Acute kidney injury; Critical care; Renal replacement therapy; Treatment outcome.

PubMed Disclaimer

Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: GAUDRY STEPHANE reports financial support was provided by the French Government Ministry of Social Affairs Health and Women’s Rights. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Study design. AKI: acute kidney injury; RRT: renal replacement therapy; CRRT: continuous renal replacement therapy; IHD: intermittent haemodialysis; CKD: chronic kidney disease; GFR: glomerular filtration rate.
See this image and copyright information in PMC

References

    1. Hoste E.A.J., Bagshaw S.M., Bellomo R., Cely C.M., Colman R., Cruz D.N., et al. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. août. 2015;41(8):1411–1423. - PubMed
    1. Ronco C., Bellomo R., Kellum J.A. Acute kidney injury. Lancet Lond Engl. 2019;394(10212):1949–1964. 23. - PubMed
    1. Bagshaw S.M., Darmon M., Ostermann M., Finkelstein F.O., Wald R., Tolwani A.J., et al. Current state of the art for renal replacement therapy in critically ill patients with acute kidney injury. Intensive Care Med. juin. 2017;43(6):841–854. - PubMed
    1. Truche A.S., Darmon M., Bailly S., Clec’h C., Dupuis C., Misset B., et al. Continuous renal replacement therapy versus intermittent hemodialysis in intensive care patients: impact on mortality and renal recovery. Intensive Care Med. sept. 2016;42(9):1408–1417. - PubMed
    1. Schneider A.G., Bellomo R., Bagshaw S.M., Glassford N.J., Lo S., Jun M., et al. Choice of renal replacement therapy modality and dialysis dependence after acute kidney injury: a systematic review and meta-analysis. Intensive Care Med. juin. 2013;39(6):987–997. - PubMed

Associated data

LinkOut - more resources