早期肾功能不全患者使用小剂量多巴胺：一项安慰剂对照随机试验。澳大利亚和新西兰重症监护学会（ANZICS）临床试验组。

Low-dose dopamine in patients with early renal dysfunction: a placebo-controlled randomised trial. Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group.

作者信息

Bellomo R, Chapman M, Finfer S, Hickling K, Myburgh J

出版信息

Lancet. 2000;356(9248):2139-43. doi: 10.1016/s0140-6736(00)03495-4.

DOI:10.1016/s0140-6736(00)03495-4

PMID:11191541

Abstract

BACKGROUND

Low-dose dopamine is commonly administered to critically ill patients in the belief that it reduces the risk of renal failure by increasing renal blood flow. However, these effects have not been established in a large randomised controlled trial, and use of dopamine remains controversial. We have done a multicentre, randomised, double-blind, placebo-controlled study of low-dose dopamine in patients with at least two criteria for the systemic inflammatory response syndrome and clinical evidence of early renal dysfunction (oliguria or increase in serum creatinine concentration).

METHODS

328 patients admitted to 23 participating intensive-care units (ICUs) were randomly assigned a continuous intravenous infusion of low-dose dopamine (2 microg kg(-1) min(-1)) or placebo administered through a central venous catheter while in the ICU. The primary endpoint was the peak serum creatinine concentration during the infusion. Analyses excluded four patients with major protocol violations.

FINDINGS

The groups assigned dopamine (n=161) and placebo (n=163) were similar in terms of baseline characteristics, renal function, and duration of trial infusion. There was no difference between the dopamine and placebo groups in peak serum creatinine concentration during treatment (245 [SD 144] vs 249 [147] micromol/L; p=0.93), in the increase from baseline to highest value during treatment (62 [107] vs 66 [108] micromol/L; p=0.82), or in the numbers of patients whose serum creatinine concentration exceeded 300 micromol/L (56 vs 56; p=0.92) or who required renal replacement therapy (35 vs 40; p=0.55). Durations of ICU stay (13 [14] vs 14 [15] days; p=0.67) and of hospital stay (29 [27] vs 33 [39] days; p=0.29) were also similar. There were 69 deaths in the dopamine group and 66 in the placebo group.

INTERPRETATION

Administration of low-dose dopamine by continuous intravenous infusion to critically ill patients at risk of renal failure does not confer clinically significant protection from renal dysfunction.

摘要

背景

低剂量多巴胺常用于危重病患者，人们认为它可通过增加肾血流量来降低肾衰竭风险。然而，这些作用尚未在大型随机对照试验中得到证实，多巴胺的使用仍存在争议。我们对至少符合两项全身炎症反应综合征标准且有早期肾功能不全临床证据（少尿或血清肌酐浓度升高）的患者进行了一项关于低剂量多巴胺的多中心、随机、双盲、安慰剂对照研究。

方法

23个参与研究的重症监护病房（ICU）收治的328例患者在ICU期间通过中心静脉导管被随机分配接受持续静脉输注低剂量多巴胺（2微克/千克/分钟）或安慰剂。主要终点是输注期间血清肌酐浓度峰值。分析排除了4例严重违反方案的患者。

结果

分配到多巴胺组（n = 161）和安慰剂组（n = 163）的患者在基线特征、肾功能和试验输注持续时间方面相似。治疗期间多巴胺组和安慰剂组的血清肌酐浓度峰值（245[标准差144]对249[147]微摩尔/升；p = 0.93）、从基线到治疗期间最高值的升高幅度（62[107]对66[108]微摩尔/升；p = 0.82），或血清肌酐浓度超过300微摩尔/升的患者数量（56对56；p = 0.92）或需要肾脏替代治疗的患者数量（35对40；p = 0.55）均无差异。ICU住院时间（13[14]对14[15]天；p = 0.67）和住院时间（29[27]对33[39]天；p = 0.29）也相似。多巴胺组有69例死亡，安慰剂组有66例死亡。