METHODS: We conducted a randomized, double-blind, pilot trial in which 29 adult patients scheduled for CABG were randomly assigned (on a 1:1 basis) to receive either 1.5 ml/kg Intralipid 20% or Ringer\'s Lactate 3 min before aortic cross unclamping. The primary endpoint was the 72-h area under the curve (AUC) for troponin I.
RESULTS: Of the 29 patients randomized, 26 were included in the study (two withdrew consent and one was excluded before surgery). The 72-h AUC for troponin I did not significantly differ between the control and Intralipid group (546437 ± 205518 versus 487561 ± 115724 arbitrary units, respectively; P = 0.804). Other outcomes (including 72-h AUC for CK-MB, C-reactive protein, need for defibrillation, time to extubation, length of ICU and hospital stay, and serious adverse events) were similar between the two groups.
CONCLUSIONS: In patients undergoing CABG on CPB, Intralipid did not limit myocardial IRI compared to placebo.
BACKGROUND: ClinicalTrials.gov Identifier: NCT02807727 (registration date: 16 June 2016).
方法:我们进行了随机,双盲,试验中,29例CABG成年患者被随机分配(以1:1为基础),在主动脉阻断前3分钟接受1.5ml/kg20%Intralipal或Ringer乳酸。主要终点是肌钙蛋白I的72小时曲线下面积(AUC)。
结果:在随机分组的29例患者中,26人被纳入研究(2人撤回同意,1人在手术前被排除)。肌钙蛋白I的72小时AUC在对照组和内脂组之间没有显着差异(546437±205518与487561±115724任意单位,分别;P=0.804)。其他结果(包括CK-MB的72小时AUC,C反应蛋白,需要除颤,拔管时间,ICU的长度和住院时间,和严重不良事件)两组之间相似。
结论:在CPB下接受CABG的患者中,与安慰剂相比,脂质内脂不限制心肌IRI。
背景:ClinicalTrials.gov标识符:NCT02807727(注册日期:2016年6月16日)。