EVLWI Exhibits Pulmonary and Systemic Permeability in Sepsis Related ALI/ARDS
2015年7月27日 更新者：Chung Fu-Tsai、Chang Gung Memorial Hospital
Extravascular Lung Water Index Exhibits Pulmonary and Systemic Permeability in Patients With Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome.
To investigate the possible mechanisms of pulmonary and systemic permeability change including cytokine, extravascular lung water index (EVLWI), and oxygenation parameters in patients with sepsis related acute lung injury (ALI)/acute respiratory distress syndrome (ARDS).
研究概览
详细说明
This investigation is a prospective control study. Informed consents will be obtained from all patients or their surrogates prior to the procedure of EVLWI measurement and blood sampling for molecular measurement including cytokines.
From July 2011 to June 2014, consecutive septic patients with ARDS in intensive care units (ICUs) will be enrolled at Chang Gung Memorial Hospital, a university-affiliated hospital in Taiwan. EVLWI will be measured by PiCCO monitoring system. Serum cytokine such as endothelin-1, TNF-alfa, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured.
研究类型
观察性的
注册 (预期的)
60
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
-
-
-
Linkou、台湾、333
- 招聘中
- Chung Gung Memorial Hospital
-
接触：
- Fu-Tsai Chung, MD
- 电话号码：8468 +886-3-3281200
- 邮箱：vikingchung@yahoo.com.tw
-
首席研究员：
- Fu-Tsai Chung, MD
-
-
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
20年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Septic patients receiving endotracheal mechanical ventilation for hypoxemic acute respiratory failure were eligible if the following criteria were met for no more than 48 hours before enrollment: ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FIO2) no greater than 300 mm Hg at time of enrollment, recent appearance of bilateral pulmonary infiltrates consistent with edema, and no clinical evidence of left atrial hypertension (pulmonary-capillary wedge pressure _18 mm Hg, when available).
描述
Inclusion Criteria:
- sepsis in ICU within 48 hours,
- mechanical ventilator use,
- PaO2/FiO2 < 300,
Exclusion Criteria:
- age younger than 20 years,
- known pregnancy,
- participation in another trial within 30 days before meeting the eligibility criteria, and
- terminal malignancy.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
patients with sepsis related ALI/ARDS.
Consecutive septic patients with ALI/ARDS in medical intensive care units (ICUs) will be enrolled.
EVLWI will be measured by PiCCO monitoring system.
|
The EVLW measurement will be based on transpulmonary thermodilution method.
This method was recently introduced as part of the PiCCO plus system (Pulsion Medical System, Munich, Germany), for monitoring severe sepsis patients being treated in medical ICUs.
This method only used a single indicator (cold saline solution), and demonstrated a satisfactory correlation with the gravimetric method.
A 4-F arterial catheter (PulsiocathPV2014L16; Pulsion Medical Systems, Munich, Germany) was positioned in the descending aorta via the femoral artery using the Seldinger technique.
The femoral arterial catheter and a standard central venous catheter were connected to pressure transducers, and also to an integrated bedside monitor (PiCCO; Pulsion Medical Systems).
|
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 |
|---|---|---|
|
vascular permeability of sepsis related ALI/ARDS
大体时间：3 days
|
vascular permeability (day 1 and 3 EVLWI, lung permeability, 24hr fluid balance, microalbuminuria, DAMPs/RAGE, Ang-1, 2 and TIE-2 level, will be detected in the blood sampling) and sepsis-induced ALI/ARDS.
|
3 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
relationship between endothelial injury and vascular permeability.
大体时间：3 days
|
relationship between endothelial injury (serum TM, vWF, VEGF, TIE-2 increase and imbalance of ANG-1/ANG-2) and vascular permeability in patients with sepsis related ALI/ARDS.
|
3 days
|
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。
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
2011年7月1日
初级完成 (预期的)
2016年12月1日
研究完成 (预期的)
2017年1月1日
研究注册日期
首次提交
2012年9月23日
首先提交符合 QC 标准的
2012年9月26日
首次发布 (估计)
2012年9月27日
研究记录更新
最后更新发布 (估计)
2015年7月28日
上次提交的符合 QC 标准的更新
2015年7月27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.