Microcirculatory Effects of Methylene Blue in Vasoplegic Shock After Cardiopulmonary Bypass: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in tissue oxygenation (resaturation speed expressed as %/sec) during the vessel obstruction test.
研究概览
简要总结
International guidelines recommend Methylene Blue (MB) as a second-line drug in the treatment of norepinephrine refractory vasoplegic shock (VS) after Cardiopulmonary Bypass CPB. Macrocirculatory effects of MB in this setting are now well established but microcirculatory effects of MB remain unknown.
The purpose of this study is to assess the micro vascular effects of a single administration of methylene blue (1.5 mg/kg over 30 minutes) for norepinephrine-refractory VS post CPB.
Microcirculatory effect will be monitored before and one hour after MB infusion through cutaneous refill time, video microscopy measurements of the sublingual microcirculation and tissue oxygen saturation combined with vascular occlusion test (VOT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients receiving methylene blue prescribed by the clinician in charge of the patient
- •patient receiving a dose of norepinephrine > 0.5µg/kg/min
- •normal or increase cardiac (> 2 L.min-1.m-2) at the time of inclusion
- •vasoplegic syndrome post cardiopulmonary bypass for cardiac surgery
排除标准
- •the need for hemodynamic intervention during the time of study (fluid resuscitation, introduction of inotropic or vasopressor support, change in inotropic support dose)
- •age under 18 years
结局指标
主要结局
Change in tissue oxygenation (resaturation speed expressed as %/sec) during the vessel obstruction test.
时间窗: one hour after the start of methylene blue infusion
The resaturation speed during reperfusion is defined as maximum StO2 - minimum StO2 /time of reperfusion. Tissue oxygen saturation (StO2) will be measured by near-infrared reflectance spectroscopy (NIRS) optode applied to the medial surface of the left or right forearm, 5 cm below the elbow. The sensor will be connected to the four-wavelength O3 Regional Oximetry device (Masimo Incorporation). All StO2 values will be recorded continuously and read every second. Data will be recorded online, transferred to a laptop with a specific software designed by Masimo (Masimo Instrument Configuration Tool (MICT) Version 1.0.4.9), and stored for further analysis. After completion of a baseline set of measurements for each patient, a vascular occlusion test (VOT) will be then perform using a manual pneumatic cuff inflator (Spengler SAS, Antony, France) positioned at the upper extremity of the ipsilateral upper limb.
次要结局
- Video microscopy measurements of the sublingual microcirculation(one hour after the start of methylene blue infusion)
- Cutaneous and gingival refill time(one hour after the start of methylene blue infusion)
- Metabolic variables(one hour after the start of methylene blue infusion)