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The Artificial Kidney Initiation in Kidney Injury 2 (AKIKI2): study protocol for a randomized controlled trial.
Gaudry, Stéphane; Hajage, David; Martin-Lefevre, Laurent; Louis, Guillaume; Moschietto, Sébastien; Titeca-Beauport, Dimitri; La Combe, Béatrice; Pons, Bertrand; de Prost, Nicolas; Besset, Sébastien; Combes, Alain; Robine, Adrien; Beuzelin, Marion; Badie, Julio; Chevrel, Guillaume; Reignier, Jean; Bohé, Julien; Coupez, Elisabeth; Chudeau, Nicolas; Barbar, Saber; Vinsonneau, Christophe; Forel, Jean-Marie; Thevenin, Didier; Boulet, Eric; Lakhal, Karim; Aissaoui, Nadia; Grange, Steven; Leone, Marc; Lacave, Guillaume; Nseir, Saad; Poirson, Florent; Mayaux, Julien; Asehnoune, Karim; Geri, Guillaume; Klouche, Kada; Thiery, Guillaume; Argaud, Laurent; Ricard, Jean-Damien; Quenot, Jean-Pierre; Dreyfuss, Didier.
Afiliación
  • Gaudry S; French National Institute of Health and Medical Research (INSERM), UMR_S1155, Remodeling and Repair of Renal Tissue, Hôpital Tenon, Sorbonne Université, F-75020, Paris, France.
  • Hajage D; AP-HP, Hôpital Avicenne, Service de Réanimation Médico-Chirurgicale, 125 Rue de Stalingrad, 93000, Bobigny, France.
  • Martin-Lefevre L; Health Care Simulation Center, UFR SMBH, Université Paris 13, Sorbonne Paris Cité, Bobigny, France.
  • Louis G; AP-HP, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, CIC-1421, F75013, Paris, France.
  • Moschietto S; Réanimation polyvalente, CHR départementale La Roche Sur Yon, 85025, La Roche Sur Yon, France.
  • Titeca-Beauport D; Réanimation polyvalente, CHR Metz-Thionville Hôpital de Mercy, 57085, Metz, France.
  • La Combe B; Réanimation polyvalente, CHG d'Avignon Henri Duffaut, 84902, Avignon, France.
  • Pons B; Réanimation médicale, CHU d'Amiens Picardie, 80054, Amiens, France.
  • de Prost N; Réanimation, CH de Bretagne Sud, 56322, Lorient, France.
  • Besset S; Réanimation, CHU Pointe-a-Pitre/Abymes, 97159, Pointe-a-Pitre, France.
  • Combes A; Réanimation médicale, Hôpital Henri Mondor, 94010, Créteil, France.
  • Robine A; Service de Réanimation Médico-Chirurgicale, AP-HP, Hôpital Louis Mourier, 178 rue des Renouillers, F-92700, Colombes, France.
  • Beuzelin M; Service de Réanimation Médicale, AP-HP, Hôpital Pitié Salpêtrière, 75013, Paris, France.
  • Badie J; Réanimation Soins continus, CH de Bourg-en-Bresse - Fleyriat, 01012, Bourg-en-Bresse, France.
  • Chevrel G; Réanimation polyvalente, CH de Dieppe, 76020, Dieppe, France.
  • Reignier J; Réanimation polyvalente, Hôpital Nord Franche-Comte CH Belfort, 90016, Belfort, France.
  • Bohé J; Réanimation polyvalente, CH Sud Francilien, 91106, Corbeil Essones, France.
  • Coupez E; Réanimation médicale, Hôtel Dieu, 44035, Nantes, France.
  • Chudeau N; Anesthésie réanimation médicale et chirurgicale, CH Lyon Sud, 69495, Pierre Benite,, France.
  • Barbar S; Réanimation polyvalente, Hôpital G. Montpied, 63003, Clermont Ferrand, France.
  • Vinsonneau C; Réanimation médico-chirurgicale, CH du Mans, 72037, Le Mans, France.
  • Forel JM; Réanimation, Hôpital Caremeau, 30029, Nimes, France.
  • Thevenin D; Réanimation et USC, CH Bethune Beuvry - Bermont et Gauthier, 62408, Bethune, France.
  • Boulet E; Réanimation médicale, Hôpital Nord, 13015, Marseille, France.
  • Lakhal K; Réanimation et USC, CH Dr Schaffner, 62307, Lens, France.
  • Aissaoui N; Réanimation et USC, GH Carnelle Portes de l'Oise, 95260, Beaumont sur Oise, France.
  • Grange S; Anesthésie Réanimation, hôpital Nord laennec, 44093, Nantes, France.
  • Leone M; Réanimation médicale, Hôpital Georges Pompidou, 75014, Paris, France.
  • Lacave G; Réanimation médicale, CHU Rouen, 76031, Rouen, France.
  • Nseir S; Anesthésie Réanimation, Hôpital Nord, 13015, Marseille, France.
  • Poirson F; Réanimation médico-chirurgicale, Hôpital André Mignot, 78000, Versailles, France.
  • Mayaux J; Réanimation médicale, CHRU de Lille, Hôpital Roger Salengro, 59037, Lille, France.
  • Asehnoune K; AP-HP, Hôpital Avicenne, Service de Réanimation Médico-Chirurgicale, 125 Rue de Stalingrad, 93000, Bobigny, France.
  • Geri G; Pneumologie et Réanimation médicale, Hôpital Pitié Salpêtrière, 75013, Paris, France.
  • Klouche K; Anesthésie-réanimation, Hôtel Dieu, 44035, Nantes, France.
  • Thiery G; Réanimation médico-chirurgicale, Hôpital Ambroise Paré, 92100, Boulogne-Billancourt, France.
  • Argaud L; Médecine Intensive Réanimation, Hôpital lapeyronnie, 34295, Montpellier, France.
  • Ricard JD; Réanimation médicale, CHU Saint Etienne, 42270, Saint Priest en Jarez, France.
  • Quenot JP; Réanimation médicale, Hôpital Edouard Herriot, 69437, Lyon, France.
  • Dreyfuss D; Service de Réanimation Médico-Chirurgicale, AP-HP, Hôpital Louis Mourier, 178 rue des Renouillers, F-92700, Colombes, France.
Trials ; 20(1): 726, 2019 Dec 16.
Article en En | MEDLINE | ID: mdl-31843007
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. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03396757. Registered on 11 January 2018.
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Terapia de Reemplazo Renal / Lesión Renal Aguda / Tiempo de Tratamiento / Riñón / Riñones Artificiales Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Risk_factors_studies Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2019 Tipo del documento: Article País de afiliación: Francia

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Terapia de Reemplazo Renal / Lesión Renal Aguda / Tiempo de Tratamiento / Riñón / Riñones Artificiales Tipo de estudio: Clinical_trials / Diagnostic_studies / Observational_studies / Risk_factors_studies Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2019 Tipo del documento: Article País de afiliación: Francia