Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Perfusion (as Determined by Laser Doppler Measurements)
研究概览
简要总结
The goal of this project is to determine if performing a "chemical sympathectomy" by injecting botulinum toxin A in critically ill patients on vasopressors can treat digital ischemia. This is a prospective, non-randomized pilot study designed to demonstrate proof of concept. We propose to study patients in the intensive care units of Duke Hospital who, secondary to exposure to vasoactive medications used to maintain acceptable blood pressures, have developed signs and symptoms of digital ischemia. A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. There were no major adverse events reported by the product information sheet or in other related studies of Botox for digital ischemia.
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
- •Be admitted to the ICU
- •Have digital ischemia and
- •Be on a vasopressor infusion
排除标准
- •Patients with a history of systemic sclerosis
- •Patients actively receiving aminoglycoside antibiotics - aminoglycosides may potentiate the effect of Botox
- •Patients who have previously received botulinum toxin (A or B) injections
- •Patients with a history of disorders of neuromuscular transmission (e.g myasthenia gravis, Lambert-Eaton, etc.) - Botox may have a lasting effect in these patients given their disorder
- •Patients with clinical evidence of an infection in either forearm or hand
- •Patients with a history of sensitivity to albumin - Botox is sold in powder form and there is albumin in the formulation
- •Pregnancy - Botox is a class C medication
- •Rheumatoid Arthritis
- •Upper extremity arterio-venous graft or fistula
- •Digital necrosis
- •History of hand amputation
- •Patients whom the intensive care attending physician deems will expire within 48 hours
研究组 & 干预措施
Botox injection
Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia
干预措施: Injection of botulinum toxin A (Drug)
结局指标
主要结局
Perfusion (as Determined by Laser Doppler Measurements)
时间窗: 12 months
A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. Results for the experimental and control groups will be plotted and displayed graphically as percent change in Doppler flow (y-axis) and time (x-axis).
次要结局
- Digital Amputations(12 months)