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非诺多泮输注用于高危心脏手术患者的肾脏保护:一项随机临床研究。

Fenoldopam infusion for renal protection in high-risk cardiac surgery patients: a randomized clinical study.

作者信息

Cogliati Andrea A, Vellutini Raffaella, Nardini Antonia, Urovi Sali, Hamdan Mazen, Landoni Giovanni, Guelfi Paolo

机构信息

Department of Anesthesia and Intensive Care, Villa Maria Cecilia Hospital, Cotignola, Ravenna, Italy.

出版信息

J Cardiothorac Vasc Anesth. 2007 Dec;21(6):847-50. doi: 10.1053/j.jvca.2007.02.022. Epub 2007 Jun 15.

DOI:10.1053/j.jvca.2007.02.022
PMID:18068064
Abstract

OBJECTIVE

The purpose of this study was to evaluate the renoprotective effects of fenoldopam in patients at high risk of postoperative acute kidney injury undergoing elective cardiac surgery requiring cardiopulmonary bypass.

DESIGN

A double-blind randomized clinical trial.

SETTING

Hospital.

PARTICIPANTS

One hundred ninety-three patients.

INTERVENTIONS

Patients undergoing cardiac surgery were randomly assigned to receive a continuous infusion of fenoldopam, 0.1 microg/kg/min (95 patients), or placebo (98 patients) for 24 hours. Patients were included if at least 1 of the following risk factors was present: preoperative serum creatinine > or =1.5 mg/dL, age >70 years, diabetes mellitus, or prior cardiac surgery. Serum creatinine and urinary output were measured at baseline (T1), 24 hours (T2), and 48 hours after surgery (T3). Acute kidney injury was defined as a postoperative serum creatinine level of > or =2 mg/dL with an increase in serum creatinine level of 0.7 mg/dL or greater from preoperative to maximum postoperative values.

MEASUREMENTS AND MAIN RESULTS

Acute kidney injury developed in 12 of 95 (12.6%) patients receiving fenoldopam and in 27 of 98 (27.6%) patients receiving placebo (p = 0.02), whereas renal replacement therapy was started in 0 of 95 and 8 of 98 (8.2%) patients, respectively (p = 0.004). Serum creatinine was similar at baseline (1.8 +/- 0.4 mg/dL v 1.9 +/- 0.3 mg/dL) in the fenoldopam and placebo groups but differed significantly (p < 0.001 and p < 0.001) 24 hours (1.6 +/- 0.2 mg/dL v 2.5 +/- 0.6 mg/dL) and 48 hours (1.5 +/- 0.3 mg/dL v 2.8 +/- 0.4 mg/dL) after the operation.

CONCLUSIONS

A 24-hour infusion of 0.1 mug/kg/min of fenoldopam prevented acute kidney injury in a high-risk population undergoing cardiac surgery.

摘要

目的

本研究旨在评估非诺多泮对接受需要体外循环的择期心脏手术且术后发生急性肾损伤风险较高患者的肾脏保护作用。

设计

双盲随机临床试验。

地点

医院。

参与者

193例患者。

干预措施

接受心脏手术的患者被随机分配接受持续输注非诺多泮,剂量为0.1微克/千克/分钟(95例患者),或安慰剂(98例患者),持续24小时。若患者存在以下至少1项危险因素,则纳入研究:术前血清肌酐≥1.5毫克/分升、年龄>70岁、糖尿病或既往心脏手术史。在基线(T1)、术后24小时(T2)和48小时(T3)测量血清肌酐和尿量。急性肾损伤定义为术后血清肌酐水平≥2毫克/分升,且血清肌酐水平较术前至术后最高值升高0.7毫克/分升或更多。

测量指标及主要结果

接受非诺多泮治疗的95例患者中有12例(12.6%)发生急性肾损伤,接受安慰剂治疗的98例患者中有27例(27.6%)发生急性肾损伤(p = 0.02),而分别有0例和8例(8.2%)患者开始接受肾脏替代治疗(p = 0.004)。非诺多泮组和安慰剂组基线时血清肌酐相似(1.8±0.4毫克/分升对1.9±0.3毫克/分升),但术后24小时(1.6±0.2毫克/分升对2.5±0.6毫克/分升)和48小时(1.5±0.3毫克/分升对2.8±0.4毫克/分升)时差异有统计学意义(p<0.001和p<0.001)。

结论

以0.1微克/千克/分钟的剂量持续输注非诺多泮24小时可预防接受心脏手术的高危人群发生急性肾损伤。

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