The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation: a Randomized, Controlled Clinical Trial in Patients Receiving Peripheral Vascular Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in temperature gradient at 3h post-surgery
研究概览
简要总结
The aim of this study was to investigate the effect of a 24- hrs L-arginine infusion on hemodynamic and on parameters of microcirculation in patients with peripheral arterial occlusive disease (PAOD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female or male patients receiving peripheral bypass surgery
- •age between 55 and 75 years
排除标准
- •metabolic acidosis
研究组 & 干预措施
Placebo
NaCl 0.9% intravenously for 24 hours after induction of anaesthesia
干预措施: Placebo (Dietary Supplement)
Arginine
L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia
干预措施: Arginine (Dietary Supplement)
结局指标
主要结局
Change from baseline in temperature gradient at 3h post-surgery
时间窗: baseline and 3h post-surgery
One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C.
次要结局
- Change from baseline in Laser Doppler blood perfusion imaging at 1h(baseline & 1h post-surgery)
- Change from baseline in Laser Doppler blood perfusion imaging at 2h(baseline & 2h post-surgery)
- Change from baseline in Laser Doppler blood perfusion imaging at 3h(baseline & 3h post-surgery)
- Change from baseline in Laser Doppler blood perfusion imaging at 24h(baseline & 24h post-surgery)
- Change from baseline in Laser Doppler blood perfusion imaging at 48h(baseline & 48h post-surgery)
- Change from baseline in asymmetric dimethylarginine (ADMA) at 3h(baseline & 3h post-surgery)
- Change from baseline in asymmetric dimethylarginine (ADMA) at 24h(baseline & 24h post-surgery)
- Change from baseline in asymmetric dimethylarginine (ADMA) at 48h(baseline & 48h post-surgery)
- Change from baseline in plasma arginine concentration at 3h(baseline & 3h post-surgery)
- Change from baseline in plasma arginine concentration at 24h(baseline & 24h post-surgery)
- Change from baseline in plasma arginine concentration at 48h(baseline & 48h post-surgery)
- Change from baseline in temperature gradient at 1h(baseline & 1h post-surgery)
- Change from baseline in temperature gradient at 2h(baseline & 2h post-surgery)
- Change from baseline in temperature gradient at 24h(baseline & 24h post-surgery)
- Change from baseline in temperature gradient at 48h(baseline & 48h post-surgery)
研究者
Ass.-Prof. DI Dr. Barbara Wessner
Ass.-Prof. DI Dr.
Medical University of Vienna