Hammond Naomi E, Bellomo Rinaldo, Gallagher Martin, Gattas David, Glass Parisa, Mackle Diane, Micallef Sharon, Myburgh John, Saxena Manoj, Taylor Colman, Young Paul, Finfer Simon
Critical Care and Trauma Division, The George Institute for Global Health, Sydney, NSW, Australia.
Intensive Care Unit, Austin Hospital, Melbourne, VIC, Australia.
Crit Care Resusc. 2017 Sep;19(3):239-246.
0.9% sodium chloride (saline) is the most commonly administered resuscitation fluid on a global basis but emerging evidence suggests that its high chloride content may have important adverse effects.
To describe the study protocol for the Plasma- Lyte 148 v Saline study, which will test the hypothesis that in critically ill adult patients the use of Plasma-Lyte 148 (a buffered crystalloid solution) for fluid therapy results in different 90-day all-cause mortality when compared with saline.
We will conduct this multicentre, blinded, randomised controlled trial in approximately 50 intensive care units in Australia and New Zealand. We will randomly assign 8800 patients to either Plasma-Lyte 148 or saline for all resuscitation fluid, maintenance fluid and compatible drug dilution therapy while in the ICU for up to 90 days after randomisation.
The primary outcome is 90-day all-cause mortality; secondary outcomes include mean and peak creatinine concentration, incidence of renal replacement therapy, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, ICU and hospital length of stay, and quality of life and health services use at 6 months.
The PLUS study will provide high-quality data on the comparative safety and efficacy of Plasma-Lyte 148 compared with saline for resuscitation and compatible crystalloid fluid therapy in critically ill adult patients.
0.9% 氯化钠（生理盐水）是全球最常用的复苏液体，但新出现的证据表明，其高氯含量可能产生重要的不良影响。
描述“平衡液148对比生理盐水研究”的研究方案，该研究将检验以下假设：在危重症成年患者中，与生理盐水相比，使用平衡液148（一种缓冲晶体溶液）进行液体治疗会导致不同的90天全因死亡率。
我们将在澳大利亚和新西兰约50个重症监护病房进行这项多中心、双盲、随机对照试验。我们将把8800名患者随机分配接受平衡液148或生理盐水治疗，用于所有复苏液体、维持液体以及在重症监护病房内长达90天的随机分组后的兼容药物稀释治疗。
主要观察指标是90天全因死亡率；次要观察指标包括平均和峰值肌酐浓度、肾脏替代治疗的发生率、血管活性药物治疗的发生率和持续时间、机械通气的持续时间、重症监护病房和医院住院时间，以及6个月时的生活质量和卫生服务使用情况。
PLUS研究将提供关于平衡液148与生理盐水相比，在危重症成年患者复苏及兼容晶体液治疗方面的比较安全性和有效性的高质量数据。
