术前输注0.9%生理盐水进行水化以预防择期开放性腹部大手术后急性肾损伤：一项随机对照试验。

Preoperative hydration with 0.9% normal saline to prevent acute kidney injury after major elective open abdominal surgery: A randomised controlled trial.

作者信息

Serrano Ana B, Candela-Toha Angel M, Zamora Javier, Vera Jorge, Muriel Alfonso, Del Rey Jose M, Liaño Fernando

机构信息

From the Department of Anaesthesiology (ABS, AMC-T, JV); Department of Biostatistics, "CIBER Epidemiology and Public Health" (JZ, AM); Department of Biochemistry (JMdR); and Department of Nephrology, Ramón y Cajal University Hospital, Madrid, Spain (FL).

出版信息

Eur J Anaesthesiol. 2016 Jun;33(6):436-43. doi: 10.1097/EJA.0000000000000421.

DOI:10.1097/EJA.0000000000000421

PMID:26825017

Abstract

BACKGROUND

Postoperative acute kidney injury (AKI) is the second leading cause of hospital-acquired AKI. Although many preventive strategies have been tested, none of them has been totally effective.

OBJECTIVE

We investigated whether preoperative intravenous hydration with 0.9% normal saline could prevent postoperative AKI.

DESIGN

Randomised controlled trial.

SETTING

University Ramón y Cajal Hospital, Spain, from June 2006 to February 2011.

PATIENTS

Total 328 inpatients scheduled for major elective open abdominal surgery.

INTERVENTION

0.9% normal saline at a dose of 1.5 ml kg h for 12 h before surgery.

MAIN OUTCOME MEASURES

The primary outcome was the overall postoperative AKI incidence during the first week after surgery defined by risk, injury, failure, loss, end-stage kidney disease (RIFLE) and AKI network (AKIN) creatinine criteria. Secondary endpoints were the need for ICU admission, renal replacement therapy during the study period and adverse events and hospital mortality during hospital admission.

RESULTS

There was no difference in the incidence of AKI between groups: 4.7% in the normal saline group versus 5.0% in the control group and 11.4% in the 0.9% normal saline group versus 7.9% in the control group as assessed by the RIFLE and AKIN creatinine criteria, respectively. Absolute risk reductions (95% confidence interval) were -0.3% (-5.3 to 4.7%) for RIFLE and 3.5% (-10.2 to 3.6%) for AKIN. ICU admission after surgery was required in 44.5% of all participants. Only 2 (0.7%) patients required renal replacement therapy during the first week after surgery. The analysis of adverse events did not show statistically significant differences between the groups except for pain. In our population, 8 (2.4%) patients died during their hospital admission.

CONCLUSION

Intravenous hydration with 0.9% normal saline before major open abdominal surgery was not effective in preventing postoperative AKI. No safety concerns were identified during the trial.

TRIAL REGISTRATIONS

Clinical trials.gov: NCT00953940 and EUDRA CT: 2005-004755-35.

摘要

背景

术后急性肾损伤（AKI）是医院获得性AKI的第二大主要原因。尽管已经测试了许多预防策略，但没有一种是完全有效的。

目的

我们研究了术前静脉输注0.9%生理盐水是否能预防术后AKI。

设计

随机对照试验。

地点

西班牙拉蒙·y·卡哈尔大学医院，2006年6月至2011年2月。

患者

共有328例计划进行大型择期开放性腹部手术的住院患者。

干预措施

术前12小时以1.5 ml·kg·h的剂量静脉输注0.9%生理盐水。

主要观察指标

主要结局是术后第一周内根据风险、损伤、衰竭、丧失、终末期肾病（RIFLE）和AKI网络（AKIN）肌酐标准定义的总体术后AKI发生率。次要终点是入住重症监护病房（ICU）的需求、研究期间的肾脏替代治疗以及不良事件和住院期间的医院死亡率。

结果

两组之间的AKI发生率没有差异：根据RIFLE和AKIN肌酐标准评估，生理盐水组为4.7%，对照组为5.0%；0.9%生理盐水组为11.4%，对照组为7.9%。RIFLE的绝对风险降低（95%置信区间）为-0.3%（-5.3至4.7%），AKIN为3.5%（-10.2至3.6%）。所有参与者中有44.5%在术后需要入住ICU。术后第一周只有2例（0.7%）患者需要肾脏替代治疗。除疼痛外，不良事件分析未显示两组之间有统计学上的显著差异。在我们的研究人群中，有8例（2.4%）患者在住院期间死亡。