Department of Translational Physiology (ECB, CI), Academic Medical Centre, Amsterdam, The Netherlands.
Crit Care Med. 2010 Jan;38(1):93-100. doi: 10.1097/CCM.0b013e3181b02fc1.
Microcirculatory alterations have been associated with morbidity and mortality in human sepsis. Such alterations occur despite pressure-guided resuscitation. Earlier data suggested that impaired microcirculatory blood flow could be corrected with intravenous nitroglycerin in these patients. We tested this concept after fulfillment of preset systemic hemodynamic resuscitation end points in the early phase of sepsis.
Prospective, single center, randomized, placebo-controlled, double-blind clinical trial.
Closed-format 22-bed mixed intensive care unit in a tertiary teaching hospital.
Patients > or =18 yrs with sepsis, according to international criteria, and at least one early sign of organ dysfunction, as the principal reason for intensive care unit admission, were eligible for enrollment.
Patients were randomly assigned to receive nitroglycerin (n = 35) or placebo (n = 35) after fulfillment of protocol-driven resuscitation end points. This trial is registered with ClinicalTrials.gov as NCT00493415.
Primary outcome was sublingual microcirculatory blood flow of small vessels, as assessed by side-stream dark field imaging. After protocolized resuscitation, we observed recruitment of sublingual microcirculation in both groups, as indicated by a significant improvement in the microcirculatory flow index after 24 hrs, in comparison to baseline. However, no difference in the sublingual microvascular flow index was observed between groups. The median microvascular flow index in sublingual small-sized vessels was 2.71 (1.85-3) in the nitroglycerin group and 2.71 (1.27-3), p = .80, in the placebo group. In medium-sized vessels, the respective values were 3 (2.75-3) vs. 2.86 (2.19-3), p = .21, and in large-sized vessels, 3 (3-3) vs. 3 (2.89-3), p = .06. In-hospital mortality, as a secondary outcome, was 34.3% in the nitroglycerin group and 14.2% in the placebo group, p = .09.
In the context of a strict resuscitation protocol, based upon fulfillment of systemic hemodynamic end points in patients with early-phase severe sepsis or septic shock, we conclude that intravenous nitroglycerin does not promote sublingual microcirculatory blood flow.
微循环改变与人类脓毒症的发病率和死亡率有关。尽管进行了压力指导下的复苏，但仍会出现这种改变。早期数据表明，在这些患者中，静脉内给予硝酸甘油可以纠正受损的微循环血流。我们在脓毒症早期满足预设的全身血流动力学复苏终点后，对此概念进行了测试。
前瞻性、单中心、随机、安慰剂对照、双盲临床试验。
在一家三级教学医院的封闭式 22 床混合重症监护病房。
符合国际标准的>或= 18 岁的脓毒症患者，并且至少有一个早期器官功能障碍迹象，是入住重症监护病房的主要原因，有资格入组。
在满足方案驱动的复苏终点后，患者被随机分配接受硝酸甘油（n = 35）或安慰剂（n = 35）治疗。本试验在 ClinicalTrials.gov 注册为 NCT00493415。
主要结局是通过侧流暗场成像评估的舌下小血管的微循环血流。在方案化复苏后，我们观察到两组舌下微循环的募集，与基线相比，24 小时后微循环血流指数显著改善。然而，两组之间舌下微血管血流指数无差异。舌下小血管的微血管血流指数中位数为硝酸甘油组 2.71（1.85-3），安慰剂组 2.71（1.27-3），p =.80。中等大小血管中的相应值分别为 3（2.75-3）与 2.86（2.19-3），p =.21，大血管中分别为 3（3-3）与 3（2.89-3），p =.06。次要结局院内死亡率，硝酸甘油组为 34.3%，安慰剂组为 14.2%，p =.09。
在严格的复苏方案背景下，根据严重脓毒症或脓毒性休克早期患者的全身血流动力学终点，我们得出结论，静脉内给予硝酸甘油不会促进舌下微循环血流。
