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首页> 外文期刊>Trials >Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial
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Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial

机译：重症监护病房中平衡的晶体与生理盐水：一项集群随机多交叉试验的研究方案

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Background Saline, the intravenous fluid most commonly administered to critically ill adults, contains a high chloride content, which may be associated with acute kidney injury and death. Whether using balanced crystalloids rather than saline decreases the risk of acute kidney injury and death among critically ill adults remains unknown. Methods The Isotonic Solutions and Major Adverse Renal Events Trial (SMART) is a pragmatic, cluster-level allocation, cluster-level crossover trial being conducted between 1 June 2015 and 30 April 2017 in five intensive care units at Vanderbilt University Medical Center in Nashville, TN, USA. SMART compares saline (0.9% sodium chloride) with balanced crystalloids (clinician’s choice of lactated Ringer’s solution or Plasma-Lyte A?). Each intensive care unit is assigned to provide either saline or balanced crystalloids each month, with the assigned crystalloid alternating monthly over the course of the trial. All adults admitted to participating intensive care units during the study period are enrolled and followed until hospital discharge or 30?days after enrollment. The anticipated enrollment is approximately 14,000 patients. The primary outcome is Major Adverse Kidney Events within 30?days—the composite of in-hospital death, receipt of new renal replacement therapy, or persistent renal dysfunction (discharge creatinine ≥200% of baseline creatinine). Secondary clinical outcomes include in-hospital mortality, intensive care unit-free days, ventilator-free days, vasopressor-free days, and renal replacement therapy-free days. Secondary renal outcomes include new renal replacement therapy receipt, persistent renal dysfunction, and incidence of stage 2 or higher acute kidney injury. Discussion This ongoing pragmatic trial will provide the largest and most comprehensive comparison to date of clinical outcomes with saline versus balanced crystalloids among critically ill adults. Trial registration For logistical reasons, SMART was prospectively registered separately for the medical ICU (SMART-MED; ClinicalTrials.gov identifier: NCT02444988 ; registered on 11 May 2015; date of first patient enrollment: 1 June 2015) and the nonmedical ICUs (SMART-SURG; ClinicalTrials.gov identifier: NCT02547779 ; registered on 9 September 2015; date of first patient enrollment: 1 October 2015).
机译：背景生理盐水是最常用于重症成人的静脉注射液，其氯化物含量高，这可能与急性肾损伤和死亡有关。是否使用平衡的晶体而不是盐水来降低重症成人的急性肾损伤和死亡风险仍然未知。方法等渗解决方案和重大不良肾脏事件试验（SMART）是一项务实的，集群级分配，集群级交叉试验，于2015年6月1日至2017年4月30日在纳什维尔范德比尔特大学医学中心的五个重症监护病房进行，美国田纳西州。 SMART将盐水（0.9％氯化钠）与平衡的晶体（临床医生选择乳酸林格氏液或血浆Lyte A？）进行比较。每个重症监护病房每个月要提供生理盐水或平衡的晶体，在试验过程中每月要交替提供晶体。在研究期间入院的所有重症监护病房的成年人均入组，并随访至出院或入院后30天。预期的入组人数约为14,000名患者。主要结局是30天之内的重大不良肾脏事件-院内死亡，接受新的肾脏替代疗法或持续的肾功能不全（肌酐排出量≥基线肌酐的200％）的综合结果。次要临床结果包括院内死亡率，无重症监护病房日，无呼吸机病日，无血管升压药日和无肾脏替代疗法日。继发性肾脏结局包括接受新的肾脏替代疗法，持续性肾功能不全以及2期或更高水平的急性肾损伤的发生率。讨论这项正在进行的实用试验将为重症成人提供迄今为止最大，最全面的比较生理盐水与平衡晶体对临床结果的比较。试验注册由于后勤原因，前瞻性地对SMART进行了医疗ICU的单独注册（SMART-MED; ClinicalTrials.gov标识符：NCT02444988; 2015年5月11日注册;首次患者入组日期：2015年6月1日）和非医疗ICU（SMART- SURG; ClinicalTrials.gov标识符：NCT02547779;于2015年9月9日注册;首次患者入组日期：2015年10月1日）。

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