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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\u2009>\u200940\u2009mmol\/l and oliguria\/anuria >\u200972\u2009h. 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 \u201cstandard\u201d) with another in which RRT is further delayed for a longer period (termed \u201cdelayed strategy\u201d).<\/jats:p>\n<\/jats:sec>\nMethods\/design<\/jats:title>\nThis 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.<\/jats:p>\nPatients 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\u2009>\u200940\u2009mmol\/l and\/or an oliguria\/anuria for more than 72\u2009h are randomly allocated to a standard (RRT is initiated within 12\u2009h) 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\u2009mmol\/l).<\/jats:p>\nThe primary outcome will be the number of RRT-free days at day 28.<\/jats:p>\nOne interim analysis is planned. It is expected to include 810 patients in the observational stage and to randomize 270 subjects.<\/jats:p>\n<\/jats:sec>\nDiscussion<\/jats:title>\nThe 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.<\/jats:p>\n<\/jats:sec>\nTrial registration<\/jats:title>\nClinicalTrials.gov, ID: NCT03396757<\/jats:ext-link>. Registered on 11 January 2018.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13063-019-3774-9","type":"journal-article","created":{"date-parts":[[2019,12,16]],"date-time":"2019-12-16T14:02:48Z","timestamp":1576504968000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["The Artificial Kidney Initiation in Kidney Injury 2 (AKIKI2): study protocol for a randomized controlled 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The Comit\u00e9 de Protection des Personnes manage the central and the local aspects of the project.In the observational stage of the study, all patients are informed both verbally and with a written document by the principal investigator or a physician representing the investigator. Only an oral consent is required for this stage in accordance with French law.For all patients included in the randomized trial (randomization stage of the study), written informed consent is obtained by the principal investigator or a physician representing the investigator, before the person is enrolled on the study.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The authors declare that they have no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"726"}}