Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from baseline of microcirculatory flow index
研究概览
简要总结
Octreotide is used to decrease portal pressure of cirrhotic patients admitted for variceal bleeding. When patients are in haemorrhagic shock, the recommended drug to increase arterial pressure is norepinephrine. Microcirculatory effects of octreotide when it is added to noradrenaline has not been investigated yet. The aim of the study is to evaluate the effect of octreotide plus norepinephrine for patient with haemorrhagic shock after variceal bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 more than 18 years old
- •patient with liver cirrhosis
- •patient with haemorrhagic shock due to variceal bleeding
- •patient with an arterial blood pressure less than 65 mmHg despite
- •patient able to express consent
- •signed written informed consent form
- •patient covered by national health insurance
排除标准
- •patient less than 18 years old
- •patient non covered by national health insurance
- •pregnant or breast feeding patent
- •known octreotide allergy
- •cardiac arrest because of shock
- •refused consent
研究组 & 干预措施
octreotide (25 µg/hour) perfusion
octreotide (25 µg/hour) plus norepinephrine will be administered for patient with haemorrhagic shock after variceal bleeding during 2 to 5 days according recommendations and regular protocol in the medical unit
干预措施: Octreotide Injection (Drug)
结局指标
主要结局
Change from baseline of microcirculatory flow index
时间窗: 24 hours after octreotide perfusion
microcirculatory flow index will be measured with sidestream dark field handheld microscope. Baseline is before octreotide perfusion. Flow characteristics of the microvasculature will be quantified using the microcirculatory flow index (MFI) according to the recommendations from the consensus on microcirculatory imaging by De Backer et al. This index will be calculated after the image will be divided into four quadrants, and the predominant type of flow (absent = 0, intermittent = 1, sluggish = 2, abnormal = 3, and hyperdynamic = 4) would be estimated in the vessels smaller than 25 μm by the operator. The final MFI score is a value obtained from the average score of the four areas.
次要结局
- functional capillary density(24 hours after octreotide perfusion)
- heart rate(24 hours after octreotide perfusion)
- ejection fraction(24 hours after octreotide perfusion)
- percentage of perfused vessels(24 hours after octreotide perfusion)
- Mean arterial pressure(24 hours after octreotide perfusion)