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The Artificial Kidney Initiation in Kidney Injury 2 (AKIKI2): study protocol for a randomized controlled trial

Stéphane Gaudry 1, 2 David Hajage 3 Laurent Martin-Lefevre 4 Guillaume Louis 5 Sébastien Moschietto Dimitri Titeca-Beauport 6 Béatrice La Combe 7 Bertrand Pons Nicolas de Prost 8 Sébastien Besset 9 Alain Combes Adrien Robine Marion Beuzelin 10 Julio Badie 11 Guillaume Chevrel Jean Reignier 12 Julien Bohe 13 Elisabeth Coupez 14 Nicolas Chudeau 15 Saber Barbar 16 Christophe Vinsonneau 17 Jean-Marie Forel Didier Thevenin Eric Boulet Karim Lakhal 18 Nadia Aissaoui 19 Steven Grange 20 Marc Leone 21, 22 Guillaume Lacave Saad Nseir 23 Florent Poirson Julien Mayaux 24 Karim Asehnoune 25 Guillaume Geri 26 Kada Klouche 27, 28 Guillaume Thiery 29 Laurent Argaud Jean-Damien Ricard 7 Jean-Pierre Quenot 30 Didier Dreyfuss 1
Abstract : Background: The Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a delayed renal replacement therapy (RRT) strategy for severe acute kidney injury (AKI) in critically ill patients was safe and associated with major reduction in RRT initiation compared with an early strategy. The five criteria which mandated RRT initiation in the delayed arm were: severe hyperkalemia, severe acidosis, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration > 40 mmol/l and oliguria/anuria > 72 h. However, duration of anuria/oliguria and level of blood urea are still criteria open to debate. The objective of the study is to compare the delayed strategy used in AKIKI (now termed “standard”) with another in which RRT is further delayed for a longer period (termed “delayed strategy”). Methods/design: This is a prospective, multicenter, open-label, two-arm randomized trial. The study is composed of two stages (observational and randomization stages). At any time, the occurrence of a potentially severe condition (severe hyperkalemia, severe metabolic or mixed acidosis, acute pulmonary edema due to fluid overload resulting in severe hypoxemia) suggests immediate RRT initiation. Patients receiving (or who have received) intravenously administered catecholamines and/or invasive mechanical ventilation and presenting with AKI stage 3 of the KDIGO classification and with no potentially severe condition are included in the observational stage. Patients presenting a serum urea concentration > 40 mmol/l and/or an oliguria/anuria for more than 72 h are randomly allocated to a standard (RRT is initiated within 12 h) or a delayed RRT strategy (RRT is initiated only if an above-mentioned potentially severe condition occurs or if the serum urea concentration reaches 50 mmol/l). The primary outcome will be the number of RRT-free days at day 28. One interim analysis is planned. It is expected to include 810 patients in the observational stage and to randomize 270 subjects. Discussion: The AKIKI2 study should improve the knowledge of RRT initiation criteria in critically ill patients. The potential reduction in RRT use allowed by a delayed RRT strategy might be associated with less invasive care and decreased costs. Enrollment is ongoing. Inclusions are expected to be completed by November 2019.
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Submitted on : Thursday, May 28, 2020 - 10:15:54 AM
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Stéphane Gaudry, David Hajage, Laurent Martin-Lefevre, Guillaume Louis, Sébastien Moschietto, et al.. The Artificial Kidney Initiation in Kidney Injury 2 (AKIKI2): study protocol for a randomized controlled trial. Trials, BioMed Central, 2019, 20, pp.726. ⟨10.1186/s13063-019-3774-9⟩. ⟨hal-02417783⟩

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