• N. Engl. J. Med. · Aug 2024

    Randomized Controlled Trial Multicenter Study

    A Randomized Trial of Intravenous Amino Acids for Kidney Protection.

    • Giovanni Landoni, Fabrizio Monaco, TiLian KahLKFrom the Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute (G.L., F.M., M.B.R., A.M.S., A.F., M.G.C., G.B., A. Belletti, C.... more G., G.G., C.N., M.L., A.L.D.P., S.F., R. Labanca, M.M., R. Lembo, R. Losiggio, E.F., , Martina Baiardo Redaelli, Nikola Bradic, Marco Comis, Yuki Kotani, Claudio Brambillasca, Eugenio Garofalo, Anna Mara Scandroglio, Cristina Viscido, Gianluca Paternoster, Annalisa Franco, Sabrina Porta, Federica Ferrod, Maria Grazia Calabrò, Antonio Pisano, Igor Vendramin, Gaia Barucco, Francesco Federici, Luca Severi, Alessandro Belletti, Andrea Cortegiani, Andrea Bruni, Carola Galbiati, Angelo Covino, Ekaterina Baryshnikova, Giuseppe Giardina, Maria Venditto, Daniel Kroeller, Cristina Nakhnoukh, Lorenzo Mantovani, Simona Silvetti, Margherita Licheri, Fabio Guarracino, Rosetta Lobreglio, Ambra Licia Di Prima, Stefano Fresilli, Rosa Labanca, Marta Mucchetti, Rosalba Lembo, Rosario Losiggio, Tiziana Bove, Marco Ranucci, Evgeny Fominskiy, Federico Longhini, Alberto Zangrillo, Rinaldo Bellomo, and PROTECTION Study Group. less
    • From the Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute (G.L., F.M., M.B.R., A.M.S., A.F., M.G.C., G.B., A. Belletti, C.G., G.G., C.N., M.L., A.L.D.P., S.F., R. Labanc... more a, M.M., R. Lembo, R. Losiggio, E.F., A.Z.), Vita-Salute San Raffaele University (G.L., A.Z.), and Dipartimento di Chirurgia Cardiovascolare, Unità Operativa di Anestesia e Terapia Intensiva, IRCCS Centro Cadiologico Monzino (C.B.), Milan, S.C. Anestesia e Rianimazione Cardiovascolare, A.O. Ordine Mauriziano Umberto I di Torino, Turin (M.C., C.V., S.P., F. Ferrod), the Department of Medical and Surgical Sciences, University Hospital "R. Dulbecco," Magna Graecia University, Catanzaro (E.G., A. Bruni, F.L.), Cardiovascular Anesthesia and ICU San Carlo Hospital, Potenza (G.P., A. Covino), Cardiac Anesthesia and ICU, AORN "Dei Colli," Monaldi Hospital, Naples (A.P., M.V.), the Department of Medicine, University of Udine (I.V., T.B.), the Division of Cardiac Surgery, Azienda Sanitaria Universitaria Friuli Centrale (I.V.), and the Department of Anesthesia and Intensive Care Medicine, ASUFC University-Hospital of Central Friuli (T.B.), Udine, UOC Anestesia e Rianimazione, Azienda Ospedaliero Universitaria Sant'Andrea (F. Federici), and UO Complessa Anestesia e Rianimazione, Dipartimento Cardio-Toraco-Vascolare, Azienda Ospedaliera San Camillo Forlanini (L.S.), Rome, the Department of Precision Medicine in Medical, Surgical and Critical Care, University of Palermo, and the Department of Anesthesia Analgesia Intensive Care and Emergency, University Hospital Policlinico Paolo Giaccone, Palermo (A. Cortegiani), the Department of Cardiovascular Anesthesia and Intensive Care, IRCCS Policlinico San Donato, San Donato Milanese (E.B., M.R.), IRCCS Humanitas Research Hospital, Anestesia e Terapia Intensiva Cardiochirurgica, Rozzano (D.K.), the Department of Anesthesia and ICU Maria Cecilia Hospital GVM Care and Research, Cotignola (L.M.), the Department of Cardiac Anesthesia and Intensive Care, Ospedale Policlinico San Martino IRCCS-IRCCS Cardiovascular Network, Genoa (S.S.), the Department of Cardiothoracic and Vascular Anaesthesia and Intensive Care, Azienda Ospedaliero Universitaria Pisana, Pisa (F.G.), and the Department of Anesthesia, Intensive Care and Emergency, 'Citta della Salute e della Scienza' University Hospital, Turin (R. Lobreglio) - all in Italy; the Department of Anaesthesia, National University Hospital, Singapore (L.K.T.); the Clinic of Anesthesiology, Resuscitation, and Intensive Medicine, University Hospital Dubrava, Zagreb, and University North, Department of Nursing, Varazdin - both in Croatia (N.B.); the Department of Intensive Care Medicine, Kameda Medical Center, Kamogawa, Japan (Y.K.); and the Department of Critical Care, University of Melbourne, the Australian and New Zealand Intensive Care Research Centre, Monash University, and the Department of Intensive Care, Austin Hospital - all in Melbourne, VIC, Australia (R.B.). less
    • N. Engl. J. Med. 2024 Aug 22; 391 (8): 687698687-698.

    BackgroundAcute kidney injury (AKI) is a serious and common complication of cardiac surgery, for which reduced kidney perfusion is a key contributing factor. Intravenous amino acids increase kidney perfusion and recruit renal functional reserve. However, the efficacy of amino acids in reducing the occurrence of AKI after cardiac surgery is uncertain.MethodsIn a multinational, double-blind trial, we randomly assigned adult patients who were scheduled to undergo cardiac surgery with cardiopulmonary bypass to receive an intravenous infusion of either a balanced mixture of amino acids, at a dose of 2 g per kilogram of ideal body weight per day, or placebo (Ringer's solution) for up to 3 days. The primary outcome was the occurrence of AKI, defined according to the Kidney Disease: Improving Global Outcomes creatinine criteria. Secondary outcomes included the severity of AKI, the use and duration of kidney-replacement therapy, and all-cause 30-day mortality.ResultsWe recruited 3511 patients at 22 centers in three countries and assigned 1759 patients to the amino acid group and 1752 to the placebo group. AKI occurred in 474 patients (26.9%) in the amino acid group and in 555 (31.7%) in the placebo group (relative risk, 0.85; 95% confidence interval [CI], 0.77 to 0.94; P = 0.002). Stage 3 AKI occurred in 29 patients (1.6%) and 52 patients (3.0%), respectively (relative risk, 0.56; 95% CI, 0.35 to 0.87). Kidney-replacement therapy was used in 24 patients (1.4%) in the amino acid group and in 33 patients (1.9%) in the placebo group. There were no substantial differences between the two groups in other secondary outcomes or in adverse events.ConclusionsAmong adult patients undergoing cardiac surgery, infusion of amino acids reduced the occurrence of AKI. (Funded by the Italian Ministry of Health; PROTECTION ClinicalTrials.gov number, NCT03709264.).Copyright © 2024 Massachusetts Medical Society.

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