0.9%生理盐水与 Plasma-Lyte 作为糖尿病酮症酸中毒患儿的初始液体（SPinK 试验）：一项双盲随机对照试验。
0.9% saline versus Plasma-Lyte as initial fluid in children with diabetic ketoacidosis (SPinK trial): a double-blind randomized controlled trial.
机构信息
Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.
Division of Pediatric Endocrinology, Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education & Research, Chandigarh, India.
出版信息
Crit Care. 2020 Jan 2;24(1):1. doi: 10.1186/s13054-019-2683-3.
BACKGROUND
Acute kidney injury (AKI) is an important complication encountered during the course of diabetic ketoacidosis (DKA). Plasma-Lyte with lower chloride concentration than saline has been shown to be associated with reduced incidence of AKI in adults with septic shock. No study has compared this in DKA.
METHODS
This double-blind, parallel-arm, investigator-initiated, randomized controlled trial compared 0.9% saline with Plasma-Lyte-A as initial fluid in pediatric DKA. The study was done in a tertiary care, teaching, and referral hospital in India in children (> 1 month-12 years) with DKA as defined by ISPAD. Children with cerebral edema or known chronic kidney/liver disease or who had received pre-referral fluids and/or insulin were excluded. Sixty-six children were randomized to receive either Plasma-Lyte (n = 34) or 0.9% saline (n = 32).
MAIN OUTCOMES
Primary outcome was incidence of new or progressive AKI, defined as a composite outcome of change in creatinine (defined by KDIGO), estimated creatinine clearance (defined by p-RIFLE), and NGAL levels. The secondary outcomes were resolution of AKI, time to resolution of DKA (pH > 7.3, bicarbonate> 15 mEq/L & normal sensorium), change in chloride, pH and bicarbonate levels, proportion of in-hospital all-cause mortality, need for renal replacement therapy (RRT), and length of ICU and hospital stay.
RESULTS
Baseline characteristics were similar in both groups. The incidence of new or progressive AKI was similar in both [Plasma-Lyte 13 (38.2%) versus 0.9% saline 15 (46.9%); adjusted OR 1.22; 95% CI 0.43-3.43, p = 0.70]. The median (IQR) time to resolution of DKA in Plasma-Lyte-A and 0.9% saline were 14.5 (12 to 20) and 16 (8 to 20) h respectively. Time to resolution of AKI was similar in both [Plasma-Lyte 22.1 versus 0.9% saline 18.8 h (adjusted HR 1.72; 95% CI 0.83-3.57; p = 0.14)]. Length of hospital stay was also similar in both [Plasma-Lyte 9 (8 to 12) versus 0.9% saline 10 (8.25 to 11) days; p = 0.39].
CONCLUSIONS
The incidence of new or progressive AKI and resolution of AKI were similar in both groups. Plasma-Lyte-A was similar to 0.9% Saline in time to resolution of DKA, need for RRT, mortality, and lengths of PICU and hospital stay.
TRIAL REGISTRATION
Clinical trial registry of India, CTRI/2018/05/014042 (ctri.nic.in) (Retrospectively registered).
背景
急性肾损伤（AKI）是糖尿病酮症酸中毒（DKA）过程中常见的重要并发症。与生理盐水相比，含氯浓度较低的 Plasma-Lyte 已被证明可降低成人脓毒症休克患者 AKI 的发生率。目前尚未有研究比较过这两种液体在 DKA 中的应用。
方法
这是一项由研究者发起的、双盲、平行臂、随机对照试验，比较了 0.9%生理盐水与 Plasma-Lyte-A 在儿科 DKA 中的初始液体应用。该研究在印度一家三级保健、教学和转诊医院进行，纳入了 ISPAD 定义的 DKA 患儿（> 1 个月至 12 岁）。排除有脑水肿或已知慢性肾/肝疾病的患儿，以及已接受预转诊液体和/或胰岛素的患儿。66 名患儿被随机分为接受 Plasma-Lyte（n = 34）或 0.9%生理盐水（n = 32）。
主要结局
主要结局是新发或进展性 AKI 的发生率，定义为肌酐变化（KDIGO 定义）、估计肌酐清除率（p-RIFLE 定义）和 NGAL 水平的综合结果。次要结局包括 AKI 的缓解、DKA 缓解时间（pH > 7.3、碳酸氢盐 > 15 mEq/L 和正常意识状态）、氯、pH 和碳酸氢盐水平的变化、院内全因死亡率、需要肾脏替代治疗（RRT）以及 ICU 和住院时间。
结果
两组的基线特征相似。新发或进展性 AKI 的发生率在两组间相似[Plasma-Lyte 组 13 例（38.2%）与 0.9%生理盐水组 15 例（46.9%）；调整后的 OR 1.22；95%CI 0.43-3.43，p = 0.70]。Plasma-Lyte-A 和 0.9%生理盐水组 DKA 缓解的中位（IQR）时间分别为 14.5（12 至 20）和 16（8 至 20）小时。AKI 缓解时间在两组间相似[Plasma-Lyte 组 22.1 小时与 0.9%生理盐水组 18.8 小时（调整后的 HR 1.72；95%CI 0.83-3.57；p = 0.14）]。两组的住院时间也相似[Plasma-Lyte 组 9（8 至 12）天与 0.9%生理盐水组 10（8.25 至 11）天；p = 0.39]。
结论
两组新发或进展性 AKI 的发生率和 AKI 缓解率相似。Plasma-Lyte-A 与 0.9%生理盐水在 DKA 缓解时间、需要 RRT、死亡率以及 ICU 和住院时间方面无差异。
试验注册
印度临床试验注册处，CTRI/2018/05/014042（ctri.nic.in）（回顾性注册）。
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