Department of Cardiology, Kaiser Permanente, Los Angeles, CA, USA; Regional Cardiac Cath Lab, Kaiser Permanente, Los Angeles, CA, USA; Department of Research and Evaluations, Kaiser Permanente, Pasadena, CA, USA.
Regional Cardiac Cath Lab, Kaiser Permanente, Los Angeles, CA, USA.
Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.
The administration of intravenous fluid remains the cornerstone treatment for the prevention of contrast-induced acute kidney injury. However, no well-defined protocols exist to guide fluid administration in this treatment. We aimed to establish the efficacy of a new fluid protocol to prevent contrast-induced acute kidney injury.
In this randomised, parallel-group, comparator-controlled, single-blind phase 3 trial, we assessed the efficacy of a new fluid protocol based on the left ventricular end-diastolic pressure for the prevention of contrast-induced acute kidney injury in patients undergoing cardiac catheterisation. The primary outcome was the occurrence of contrast-induced acute kidney injury, which was defined as a greater than 25% or greater than 0·5 mg/dL increase in serum creatinine concentration. Between Oct 10, 2010, and July 17, 2012, 396 patients aged 18 years or older undergoing cardiac catheterisation with an estimated glomerular filtration rate of 60 mL/min per 1·73 m(2) or less and one or more of several risk factors (diabetes mellitus, history of congestive heart failure, hypertension, or age older than 75 years) were randomly allocated in a 1:1 ratio to left ventricular end-diastolic pressure-guided volume expansion (n=196) or the control group (n=200) who received a standard fluid administration protocol. Four computer-generated concealed randomisation schedules, each with permuted block sizes of 4, were used for randomisation, and participants were allocated to the next sequential randomisation number by sealed opaque envelopes. Patients and laboratory personnel were masked to treatment assignment, but the physicians who did the procedures were not masked. Both groups received intravenous 0·9% sodium chloride at 3 mL/kg for 1 h before cardiac catheterisation. Analyses were by intention to treat. Adverse events were assessed at 30 days and 6 months and all such events were classified by staff who were masked to treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT01218828.
Contrast-induced acute kidney injury occurred less frequently in patients in the left ventricular end-diastolic pressure-guided group (6·7% [12/178]) than in the control group (16·3% [28/172]; relative risk 0·41, 95% CI 0·22-0·79; p=0·005). Hydration treatment was terminated prematurely because of shortness of breath in three patients in each group.
Left ventricular end-diastolic pressure-guided fluid administration seems to be safe and effective in preventing contrast-induced acute kidney injury in patients undergoing cardiac catheterisation.
Kaiser Permanente Southern California regional research committee grant.
静脉输液仍然是预防对比剂急性肾损伤的基石治疗方法。然而，目前尚无明确的方案来指导这种治疗中的液体管理。我们旨在建立一种新的液体方案以预防对比剂急性肾损伤。
在这项随机、平行组、对照对照、单盲 3 期试验中，我们评估了基于左心室舒张末期压力的新液体方案预防接受心脏导管插入术的患者发生对比剂急性肾损伤的疗效。主要结局是发生对比剂急性肾损伤，定义为血清肌酐浓度升高超过 25%或超过 0.5mg/dL。2010 年 10 月 10 日至 2012 年 7 月 17 日，396 名年龄在 18 岁或以上、肾小球滤过率估计为 60mL/min/1.73m²或更低且有一个或多个以下风险因素（糖尿病、充血性心力衰竭史、高血压或年龄大于 75 岁）的患者随机分为左心室舒张末期压力指导下的容量扩张组（n=196）或对照组（n=200），对照组接受标准液体管理方案。采用 4 个计算机生成的隐藏随机分组方案，每个方案的随机分组大小均为 4，用于随机分组，参与者通过密封的不透明信封被分配到下一个连续的随机分组号。患者和实验室人员对治疗方案不知情，但进行手术的医生不知情。两组患者在心脏导管插入术前 1h 内均接受 0.9%氯化钠静脉滴注，剂量为 3mL/kg。分析采用意向治疗。在 30 天和 6 个月时评估不良事件，所有此类事件均由对治疗方案不知情的工作人员进行分类。该试验在 ClinicalTrials.gov 注册，编号为 NCT01218828。
左心室舒张末期压力指导组（6.7%[12/178]）患者发生对比剂急性肾损伤的频率低于对照组（16.3%[28/172]）（相对风险 0.41，95%CI 0.22-0.79；p=0.005）。由于每组各有 3 名患者出现呼吸困难，水化治疗提前终止。
左心室舒张末期压力指导的液体管理似乎在预防接受心脏导管插入术的患者发生对比剂急性肾损伤方面是安全且有效的。
凯撒永久南部加利福尼亚地区研究委员会资助。
