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
Year: 2025
Type: article
Study design: Study Protocol
Abstract: Background: 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.
Source: Critical Care and Resuscitation
Authors: Stéphane Gaudry, Marouane Boubaya, Guillaume Louis, Khalil Chaïbi, Bruno Mégarbane, Julien Bohe, Maxime Desgrouas, Guillaume Gele-Decaudin, Adrien Joseph, Etienne de Montmollin, Christophe Camus, Nicolas De Prost, Pierre Bailly, Samir Jaber, Nicolas Chudeau, Alexis Lambour, Adrien Robine, Béatrice La Combe, Antoine Kimmoun, Guillaume Chevrel, Laurent Argaud, Jonathan Nicolas, Guillaume Thiery, Stanislas Faguer, Mathieu Jozwiak, Jean-Damien Ricard, Damien Contou, Mehdi Marzouk, Benjamin Chousterman, Julien Cadiet, Côme Bureau, Isabelle Durand Zaleski, Patrick Rossignol, Jean-Pierre Quenot, Coralie Bloch Queyrat, Didier Dreyfuss
Institutions: Inserm, Sorbonne Université, Université Sorbonne Paris Nord, Hôpital Avicenne, Maladies rénales fréquentes et rares : des mécanismes moléculaires à la médecine personnalisée, Assistance Publique – Hôpitaux de Paris, Centre Hospitalier Régional de Metz-Thionville, Université Paris Cité, Hôpital Lariboisière, Optimisation Thérapeutique en Neuropsychopharmacologie, Hôpital Lyon Sud, Centre hospitalier universitaire d'Orléans, Hôpital Cochin, Hôpital Ambroise-Paré, Hôpital Bichat-Claude-Bernard, Centre Hospitalier Universitaire de Rennes, Centre Hospitalier Universitaire Henri-Mondor, Hôpitaux Universitaires Henri-Mondor, Université de Montpellier, Physiologie et Médecine Expérimentale du Coeur et des Muscles, Centre Hospitalier Universitaire de Montpellier, Hôpital Saint Eloi, Centre Hospitalier du Mans, Centre Hospitalier Universitaire Amiens-Picardie, Centre Hospitalier de Bretagne Sud, Centre Hospitalier Régional et Universitaire de Nancy, Centre Hospitalier Sud Francilien, Hôpital Edouard Herriot, Centre Hospitalier Universitaire de Rouen, Université de Lyon, Centre Hospitalier Universitaire de Saint-Étienne, Centre Hospitalier Universitaire de Toulouse, Hôpital Rangueil, Centre Hospitalier Universitaire de Nice, Hôpital l'Archet, Hôpital Louis-Mourier, Infection, Anti-microbiens, Modélisation, Evolution, Centre Hospitalier Victor Dupouy, Centre Hospitalier de Béthune, Marqueurs cardiovasculaires en situation de stress, Centre Hospitalier Universitaire de Nantes, Centre Hospitalier Universitaire de Lille, Hôpital Roger Salengro, Université Paris-Est Créteil, Centre de Recherche Épidémiologie et Statistique, Princess Grace Hospital Centre, Défaillance Cardiovasculaire Aiguë et Chronique, Université de Lorraine, CHU Dijon Bourgogne
Language: English
Topic: Acute Kidney Injury Research
Subfield: Nephrology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $2,300
Award: G8555079983
OpenAlex ID: W4410123374