The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation
2012年9月6日 更新者：Ass.-Prof. DI Dr. Barbara Wessner、Medical Scientific Fund of the Mayor of Vienna
The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation: a Randomized, Controlled Clinical Trial in Patients Receiving Peripheral Vascular Surgery
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).
研究概览
研究类型
介入性
注册 (实际的)
40
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Vienna、奥地利、1090
- Medical University of Vienna
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- female or male patients receiving peripheral bypass surgery
- age between 55 and 75 years
Exclusion Criteria:
- metabolic acidosis
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo
NaCl 0.9% intravenously for 24 hours after induction of anaesthesia
|
NaCl 0.9% intravenously for 24h
|
|
有源比较器：Arginine
L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia
|
L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in temperature gradient at 3h post-surgery
大体时间：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.
|
baseline and 3h post-surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Laser Doppler blood perfusion imaging at 1h
大体时间：baseline & 1h post-surgery
|
Perfusion values are expressed as arbitrary perfusion units.
|
baseline & 1h post-surgery
|
|
Change from baseline in Laser Doppler blood perfusion imaging at 2h
大体时间：baseline & 2h post-surgery
|
Perfusion values are expressed as arbitrary perfusion units.
|
baseline & 2h post-surgery
|
|
Change from baseline in Laser Doppler blood perfusion imaging at 3h
大体时间：baseline & 3h post-surgery
|
Perfusion values are expressed as arbitrary perfusion units.
|
baseline & 3h post-surgery
|
|
Change from baseline in Laser Doppler blood perfusion imaging at 24h
大体时间：baseline & 24h post-surgery
|
Perfusion values are expressed as arbitrary perfusion units.
|
baseline & 24h post-surgery
|
|
Change from baseline in Laser Doppler blood perfusion imaging at 48h
大体时间：baseline & 48h post-surgery
|
Perfusion values are expressed as arbitrary perfusion units.
|
baseline & 48h post-surgery
|
|
Change from baseline in asymmetric dimethylarginine (ADMA) at 3h
大体时间：baseline & 3h post-surgery
|
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
|
baseline & 3h post-surgery
|
|
Change from baseline in asymmetric dimethylarginine (ADMA) at 24h
大体时间：baseline & 24h post-surgery
|
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
|
baseline & 24h post-surgery
|
|
Change from baseline in asymmetric dimethylarginine (ADMA) at 48h
大体时间：baseline & 48h post-surgery
|
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
|
baseline & 48h post-surgery
|
|
Change from baseline in plasma arginine concentration at 3h
大体时间：baseline & 3h post-surgery
|
L-arginine concentration is measured by HPLC and expressed in µmol/l.
|
baseline & 3h post-surgery
|
|
Change from baseline in plasma arginine concentration at 24h
大体时间：baseline & 24h post-surgery
|
L-arginine concentration is measured by HPLC and expressed in µmol/l.
|
baseline & 24h post-surgery
|
|
Change from baseline in plasma arginine concentration at 48h
大体时间：baseline & 48h post-surgery
|
L-arginine concentration is measured by HPLC and expressed in µmol/l.
|
baseline & 48h post-surgery
|
|
Change from baseline in temperature gradient at 1h
大体时间：baseline & 1h 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.
|
baseline & 1h post-surgery
|
|
Change from baseline in temperature gradient at 2h
大体时间：baseline & 2h 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.
|
baseline & 2h post-surgery
|
|
Change from baseline in temperature gradient at 24h
大体时间：baseline & 24h 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.
|
baseline & 24h post-surgery
|
|
Change from baseline in temperature gradient at 48h
大体时间：baseline & 48h 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.
|
baseline & 48h post-surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Jörg Michael Hiesmayr, Prof. Dr.、Medical University of Vienna
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年1月1日
初级完成 (实际的)
2008年12月1日
研究完成 (实际的)
2012年1月1日
研究注册日期
首次提交
2012年9月3日
首先提交符合 QC 标准的
2012年9月6日
首次发布 (估计)
2012年9月11日
研究记录更新
最后更新发布 (估计)
2012年9月11日
上次提交的符合 QC 标准的更新
2012年9月6日
最后验证
2012年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.