Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- index of Toe and Finger Ischemia (iTFI)
研究概览
简要总结
Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive drugs such as amines. Finger necrosis (so called "blue toe syndrome") is a well documented phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Botulinum toxin is a known muscle relaxant used for a variety of medical application. Recently, several reports have demonstrated its effect in vasospastic disorders. It has also been in mice that when administered locally it has a local vasodilatory effect. The goal of this experiment is to compare the effect of Botulinum Toxin administered locally on amine induced finger necrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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 treated with vasoactive drugs (amines) and have finger/toe necrosis
排除标准
- •Sensitivity to drug (Botox) ingredients.
- •Active local limb infection
- •ICU admission due to botulism
- •Chronic muscular weakness disease, e.g., Myasthenia gravis, ALS
- •Age lower than 18
研究组 & 干预措施
Treatment
Injection of 200 units of Botulinum Toxin A (BOTOX) to a treated limb. Each limb will be divided to two levels - arterial arch and digital arteries (near MCP/MTP) levels. In each level 100 units of Botox will be injected in 6 injection points in the proximity of the arteries.
干预措施: Botox (Drug)
Control
Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.
干预措施: Placebo (Drug)
结局指标
主要结局
index of Toe and Finger Ischemia (iTFI)
时间窗: three months after drug administration
Score including: O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration
次要结局
- Amputation(Three months after drug administration)
- Patients survival(Three months after drug administration)
研究者
Dr. Amir Herman
Principal Investigator
Sheba Medical Center