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. Labanca, 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.).
N Engl J Med. 2024 Aug 22;391(8):687-698. doi: 10.1056/NEJMoa2403769. Epub 2024 Jun 12.
Acute 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.
In 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.
We 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.
Among 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.).
急性肾损伤（AKI）是心脏手术的一种严重且常见的并发症，其关键致病因素是肾脏灌注减少。静脉内给予氨基酸可增加肾脏灌注并调动肾脏功能储备。然而，氨基酸在降低心脏手术后 AKI 发生方面的疗效尚不确定。
在一项多中心、双盲试验中，我们将计划接受体外循环心脏手术的成年患者随机分配，接受静脉内输注氨基酸混合物（剂量为每天 2 克/理想体重公斤）或安慰剂（林格氏液），持续 3 天。主要结局是 AKI 的发生，定义依据为肾脏病：改善全球预后（KDIGO）肌酐标准。次要结局包括 AKI 的严重程度、肾脏替代治疗的使用和持续时间以及全因 30 天死亡率。
我们在 3 个国家的 22 个中心共招募了 3511 例患者，将 1759 例患者分配至氨基酸组，1752 例患者分配至安慰剂组。氨基酸组发生 AKI 的患者有 474 例（26.9%），安慰剂组发生 AKI 的患者有 555 例（31.7%）（相对风险，0.85；95%置信区间[CI]，0.77 至 0.94；P=0.002）。分别有 29 例（1.6%）和 52 例（3.0%）患者发生 3 期 AKI（相对风险，0.56；95%CI，0.35 至 0.87）。氨基酸组有 24 例（1.4%）患者接受肾脏替代治疗，安慰剂组有 33 例（1.9%）患者接受肾脏替代治疗。两组在其他次要结局或不良事件方面没有明显差异。
在接受心脏手术的成年患者中，输注氨基酸可降低 AKI 的发生。（由意大利卫生部资助；PROTECTION 临床试验注册编号，NCT03709264。）
