Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy During Open Surgery for Aortic Aneurysm
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Blood pressure levels
研究概览
简要总结
Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During surgery the renal arteries are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in ambulatory blood pressure levels.
详细描述
Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During the surgery the renal arteries at both sides are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Renal arterial blood flow is checked by Doppler after the freezing procedure, during the surgery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in 24h ambulatory blood pressure levels and of course safety parameters such as creatinine levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned prophylactic surgery for abdominal aortic aneurysm
排除标准
- •hypotension,
- •inability to understand study protocol
研究组 & 干预措施
Cryo-therapy
Cryo-therapy of renal arteries
干预措施: Cryo-therapy (Procedure)
Control
No intervention in renal arteries
结局指标
主要结局
Blood pressure levels
时间窗: 2 months
24 hour mean ambulatory blood pressure levels before and 2 months after surgery
次要结局
- Levels of epinephrine and nor-epinephrine in urine(before and 2 months after surgery)
研究者
Fredrik H Nystrom
MD PhD professor Head of internal medicine
University Hospital, Linkoeping