Saber D Barbar1, Raphaël Clere-Jehl1, Abderrahmane Bourredjem1, Romain Hernu1, Florent Montini1, Rémi Bruyère1, Christine Lebert1, Julien Bohé1, Julio Badie1, Jean-Pierre Eraldi1, Jean-Philippe Rigaud1, Bruno Levy1, Shidasp Siami1, Guillaume Louis1, Lila Bouadma1, Jean-Michel Constantin1, Emmanuelle Mercier1, Kada Klouche1, Damien du Cheyron1, Gaël Piton1, Djillali Annane1, Samir Jaber1, Thierry van der Linden1, Gilles Blasco1, Jean-Paul Mira1, Carole Schwebel1, Loïc Chimot1, Philippe Guiot1, Mai-Anh Nay1, Ferhat Meziani1, Julie Helms1, Claire Roger1, Benjamin Louart1, Remi Trusson1, Auguste Dargent1, Christine Binquet1, Jean-Pierre Quenot1. 1. From Réanimation Médicale, Centre Hospitalier Universitaire (CHU) de Nîmes (S.D.B., B. Louart, R.T.), and Saint Eloi, CHU de Montpellier, Université de Montpellier, and INSERM Unité 1046 (S.J.), Service de Réanimation Médicale, CHU Lapeyronie (K.K.), Montpellier, Université de Strasbourg, Faculté de Médecine, Hôpitaux Universitaires de Strasbourg, Service de Réanimation, Nouvel Hôpital Civil, Strasbourg (R.C.-J., F. Meziani, J.H.), Service de Médecine Intensive Réanimation, Hôpital Universitaire François Mitterrand, and Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC (A.D., J.-P.Q.), and Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (A.B., C.B., J.-P.Q.), Réanimation Médicale, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon (R.H.), Réanimation Polyvalente, Centre Hospitalier d'Avignon, Avignon (F. Montini), Réanimation Polyvalente, Centre Hospitalier de Bourg-en-Bresse, Bourg-en-Bresse (R.B.), Service de Médecine Intensive-Réanimation, Centre Hospitalier de La Roche-sur-Yon, La Roche-sur-Yon (C.L.), Intensive Care Unit, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Pierre-Bénite (J. Bohé), Réanimation Polyvalente, Hôpital Nord Franche-Comté, Belfort (J. Badie), Médecine Intensive Réanimation, Centre Hospitalier de Dieppe, Dieppe (J.-P.E., J.-P.R.), Service de Réanimation Médicale, CHU de Nancy-Brabois, Nancy (B. Levy), Service d'Anesthésie-Réanimation, Centre Hospitalier d'Etampes, Etampes (S.S.), Réanimation Polyvalente, Hôpital Bon Secours, Centre Hospitalier Régional de Metz, Metz (G.L.), Infection, Antimicrobiens, Modélisation, Evolution, Unité 1137, Team Decision Sciences in Infectious Disease Prevention, Control, and Care, Université Paris Diderot, Sorbonne Paris Cité, and Medical and Infectious Diseases ICU, Bichat-Claude-Bernard Hospital, Assistance Publique-Hôpitaux de Paris (L.B.), and Service de Réanimation Médicale, Hôpital Cochin (J.-P.M.), Paris, Pôle de Médecine Péri-Opératoire, GReD, and INSERM Unité 1103, CHU Clermont-Ferrand, Clermont-Ferrand (J.-M.C.), Service de Réanimation Médicale, CHU Régional de Tours, Tours (E.M.), CHU de Caen, Service de Réanimation Médicale, Caen (D.C.), Service de Réanimation Médicale (G.P.) and Service de Réanimation Chirurgicale (G.B.), CHU de Besançon, Besançon, Service de Médecine Intensive et Réanimation, Hôpital Raymond Poincaré, Garches (D.A.), Laboratory of Infection and Inflammation, INSERM Unité 1173, University of Versailles Saint-Quentin-en-Yvelines, Montigny-le-Bretonneux (D.A.), Service de Médecine Intensive Réanimation, Groupe des Hôpitaux de l'Institut Catholique de Lille, Université Catholique de Lille, Lille (T.L.), Service de Réanimation Médicale, CHU de Grenoble, Grenoble (C.S.), Service de Réanimation, Centre Hospitalier de Perigueux, Perigueux (L.C.), Service de Réanimation Polyvalente, Centre Hospitalier Général de Mulhouse, Mulhouse (P.G.), Médecine Intensive Réanimation, Centre Hospitalier Régional d'Orléans, Orléans (M.-A.N.), and Réanimation Chirurgicale-CHU de Nîmes, Nîmes (C.R.) - all in France.
Abstract
BACKGROUND: Acute kidney injury is the most frequent complication in patients with septic shock and is an independent risk factor for death. Although renal-replacement therapy is the standard of care for severe acute kidney injury, the ideal time for initiation remains controversial. METHODS: In a multicenter, randomized, controlled trial, we assigned patients with early-stage septic shock who had severe acute kidney injury at the failure stage of the risk, injury, failure, loss, and end-stage kidney disease (RIFLE) classification system but without life-threatening complications related to acute kidney injury to receive renal-replacement therapy either within 12 hours after documentation of failure-stage acute kidney injury (early strategy) or after a delay of 48 hours if renal recovery had not occurred (delayed strategy). The failure stage of the RIFLE classification system is characterized by a serum creatinine level 3 times the baseline level (or ≥4 mg per deciliter with a rapid increase of ≥0.5 mg per deciliter), urine output less than 0.3 ml per kilogram of body weight per hour for 24 hours or longer, or anuria for at least 12 hours. The primary outcome was death at 90 days. RESULTS: The trial was stopped early for futility after the second planned interim analysis. A total of 488 patients underwent randomization; there were no significant between-group differences in the characteristics at baseline. Among the 477 patients for whom follow-up data at 90 days were available, 58% of the patients in the early-strategy group (138 of 239 patients) and 54% in the delayed-strategy group (128 of 238 patients) had died (P=0.38). In the delayed-strategy group, 38% (93 patients) did not receive renal-replacement therapy. Criteria for emergency renal-replacement therapy were met in 17% of the patients in the delayed-strategy group (41 patients). CONCLUSIONS: Among patients with septic shock who had severe acute kidney injury, there was no significant difference in overall mortality at 90 days between patients who were assigned to an early strategy for the initiation of renal-replacement therapy and those who were assigned to a delayed strategy. (Funded by the French Ministry of Health; IDEAL-ICU ClinicalTrials.gov number, NCT01682590 .).
RCT Entities:
BACKGROUND:Acute kidney injury is the most frequent complication in patients with septic shock and is an independent risk factor for death. Although renal-replacement therapy is the standard of care for severe acute kidney injury, the ideal time for initiation remains controversial. METHODS: In a multicenter, randomized, controlled trial, we assigned patients with early-stage septic shock who had severe acute kidney injury at the failure stage of the risk, injury, failure, loss, and end-stage kidney disease (RIFLE) classification system but without life-threatening complications related to acute kidney injury to receive renal-replacement therapy either within 12 hours after documentation of failure-stage acute kidney injury (early strategy) or after a delay of 48 hours if renal recovery had not occurred (delayed strategy). The failure stage of the RIFLE classification system is characterized by a serum creatinine level 3 times the baseline level (or ≥4 mg per deciliter with a rapid increase of ≥0.5 mg per deciliter), urine output less than 0.3 ml per kilogram of body weight per hour for 24 hours or longer, or anuria for at least 12 hours. The primary outcome was death at 90 days. RESULTS: The trial was stopped early for futility after the second planned interim analysis. A total of 488 patients underwent randomization; there were no significant between-group differences in the characteristics at baseline. Among the 477 patients for whom follow-up data at 90 days were available, 58% of the patients in the early-strategy group (138 of 239 patients) and 54% in the delayed-strategy group (128 of 238 patients) had died (P=0.38). In the delayed-strategy group, 38% (93 patients) did not receive renal-replacement therapy. Criteria for emergency renal-replacement therapy were met in 17% of the patients in the delayed-strategy group (41 patients). CONCLUSIONS: Among patients with septic shock who had severe acute kidney injury, there was no significant difference in overall mortality at 90 days between patients who were assigned to an early strategy for the initiation of renal-replacement therapy and those who were assigned to a delayed strategy. (Funded by the French Ministry of Health; IDEAL-ICU ClinicalTrials.gov number, NCT01682590 .).
Authors: C Nusshag; C Beynon; M Dietrich; A Hecker; C Jungk; D Michalski; K Schmidt; M A Weigand; C J Reuß; M Bernhard; T Brenner Journal: Anaesthesist Date: 2019-12 Impact factor: 1.041