Department of Anesthesiology and Intensive Care, University of Rome, La Sapienza, Viale del Policlinico 155, Rome 00161, Italy.
Crit Care. 2010;14(6):R232. doi: 10.1186/cc9387. Epub 2010 Dec 23.
The purpose of the present study was to investigate microcirculatory blood flow in patients with septic shock treated with levosimendan as compared to an active comparator drug (i.e. dobutamine). The primary end point was a difference of ≥ 20% in the microvascular flow index of small vessels (MFIs) among groups.
The study was designed as a prospective, randomized, double-blind clinical trial and performed in a multidisciplinary intensive care unit. After achieving normovolemia and a mean arterial pressure of at least 65 mmHg, 40 septic shock patients were randomized to receive either levosimendan 0.2 μg·kg(-1)·min(-1) (n = 20) or an active comparator (dobutamine 5 μg·kg(-1)·min(-1); control; n = 20) for 24 hours. Sublingual microcirculatory blood flow of small and medium vessels was assessed by sidestream dark-field imaging. Microcirculatory variables and data from right heart catheterization were obtained at baseline and 24 hours after randomization. Baseline and demographic data were compared by means of Mann-Whitney rank sum test or chi-square test, as appropriate. Microvascular and hemodynamic variables were analyzed using the Mann-Whitney rank sum test.
Microcirculatory flow indices of small and medium vessels increased over time and were significantly higher in the levosimendan group as compared to the control group (24 hrs: MFIm 3.0 (3.0; 3.0) vs. 2.9 (2.8; 3.0); P = .02; MFIs 2.9 (2.9; 3.0) vs. 2.7 (2.3; 2.8); P < .001). The relative increase of perfused vessel density vs. baseline was significantly higher in the levosimendan group than in the control group (dMFIm 10 (3; 23)% vs. 0 (-1; 9)%; P = .007; dMFIs 47 (26; 83)% vs. 10 (-3; 27); P < .001). In addition, the heterogeneity index decreased only in the levosimendan group (dHI -93 (-100; -84)% vs. 0 (-78; 57)%; P < .001). There was no statistically significant correlation between systemic and microcirculatory flow variables within each group (each P > .05).
Compared to a standard dose of 5 μg·kg(-1)·min(-1) of dobutamine, levosimendan at 0.2 μg·kg(-1)·min(-1) improved sublingual microcirculatory blood flow in patients with septic shock, as reflected by changes in microcirculatory flow indices of small and medium vessels.
NCT00800306.
本研究旨在比较左西孟旦与活性对照药物（即多巴酚丁胺）治疗脓毒性休克患者的微循环血流。主要终点是小血管（MFIs）的微血管血流指数（MFI）在各组之间的差异≥20%。
该研究设计为前瞻性、随机、双盲临床试验，在多学科重症监护病房进行。在达到正常血容量和平均动脉压至少 65mmHg 后，40 例脓毒性休克患者随机接受左西孟旦 0.2μg·kg(-1)·min(-1)（n=20）或活性对照药物（多巴酚丁胺 5μg·kg(-1)·min(-1)；对照组；n=20）治疗 24 小时。通过侧流暗场成像评估小和中等血管的舌下微循环血流。在随机分组后 24 小时内获得微循环变量和右心导管术数据。使用 Mann-Whitney 秩和检验或卡方检验比较基线和人口统计学数据，视情况而定。使用 Mann-Whitney 秩和检验分析微血管和血液动力学变量。
小血管和中等血管的微循环血流指数随时间增加，左西孟旦组明显高于对照组（24 小时：MFIm 3.0（3.0；3.0）vs. 2.9（2.8；3.0）；P=.02；MFIs 2.9（2.9；3.0）vs. 2.7（2.3；2.8）；P<.001）。与基线相比，左西孟旦组的灌注血管密度相对增加明显高于对照组（dMFIm 10（3；23）% vs. 0（-1；9）%；P=.007；dMFIs 47（26；83）% vs. 10（-3；27）%；P<.001）。此外，只有左西孟旦组的异质性指数下降（dHI -93（-100；-84）% vs. 0（-78；57）%；P<.001）。在每组内，系统和微循环血流变量之间没有统计学上显著的相关性（各 P>.05）。
与标准剂量 5μg·kg(-1)·min(-1)的多巴酚丁胺相比，左西孟旦 0.2μg·kg(-1)·min(-1)改善了脓毒性休克患者的舌下微循环血流，反映在小血管和中等血管的微循环血流指数的变化。
NCT00800306。
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