Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course
2018年5月24日 更新者：Claudia Spies
Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course - a Pilot Study
A single- center prospective observational study.
This study evaluates different aspects of endothelial function.
It investigates the endothelial leakage with the venous occlusion plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing.
研究概览
地位
终止
条件
研究类型
观察性的
注册 (实际的)
47
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
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Berlin、德国、13353
- Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
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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
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
取样方法
概率样本
研究人群
Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin
描述
Inclusion Criteria:
- Offered patient information and written informed consent
Female patients aged greater than or equal to 18 years:
- for reduction of a primary ovarian tumour or recidive of an ovarian tumour
pregnant patients with:
- clinical normal pregnancy
- pregnancy with weight gain of more than 10 kg
- pregnancy and gestosis
- healthy volunteers
Exclusion Criteria:
- Persons without the capacity to consent
- Unability of German language use
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- (Unclear) history of alcohol or substances disabuse
- Coworker of the Charité
- Advanced disease of the oesophagus or upper respiratory tract
- Operation in the area of the oesophagus or nasopharynx within the last two months
- Neurological or psychiatric disease
- CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospital stay
- American Society of Anaesthesiologists (ASA) classification greater than IV
- Renal insufficiency (dependency of haemodialysis)
- Pulmonal oedema in thorax x-ray
- History of intracranial hemorrhage within one year of participation in the study
- Conditions following venous thrombosis within the last three years before study inclusion
- Inflammatory or reflective disease of blood vessels (Raynaud-Syndrome, Vasculitis)
- Inherent connective tissue disease(e.g. Marfan Syndrome)
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 |
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Perioperative ovarian cancer patients
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Pregnant patients
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Female healthy volunteers
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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 |
|---|---|---|
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Filtration coefficient
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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Endothelial parameter from the examination with venous occlusion plethysmography.
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Filtration coefficient
大体时间：up to one hour single measurement in pregnant woman
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Endothelial parameter from the examination with venous occlusion plethysmography.
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up to one hour single measurement in pregnant woman
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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All patients: Hemodynamic parameters
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF)
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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All patients: Endothelial flow-mediated vasodilatation
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Blood loss
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)
大体时间：during the operation
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during the operation
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Perioperative patients: Incidence and impact of organ dysfunctions
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Pain
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Body weight
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Satisfaction of the patients, surgeon and anesthesiologist
大体时间：on the day of surgery
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on the day of surgery
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Perioperative patients: Duration until clinical discharge criteria were satisfied
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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Postanesthesia Discharge Scoring System (PADS) for Determining Home-Readiness
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Intensive care unit average length of stay; hospital average length of stay
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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Perioperative patients: Quality of life
大体时间：perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
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Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses.
The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension.
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perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks
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Pregnant patients: History data of the pregnancy, parameter of Gestosis
大体时间：up to one hour single measurement in pregnant woman
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Gestosis: toxemia of pregnancy
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up to one hour single measurement in pregnant woman
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All patients: Immunological Markers
大体时间：perioperatively up to the fifth postoperative day in patients undergoing surgery
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Differences in selected immunologic parameters among others IL-6, IL-10
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perioperatively up to the fifth postoperative day in patients undergoing surgery
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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 (实际的)
2011年3月29日
初级完成 (实际的)
2012年9月29日
研究完成 (实际的)
2012年9月29日
研究注册日期
首次提交
2011年3月8日
首先提交符合 QC 标准的
2011年3月8日
首次发布 (估计)
2011年3月9日
研究记录更新
最后更新发布 (实际的)
2018年5月25日
上次提交的符合 QC 标准的更新
2018年5月24日
最后验证
2018年5月1日
更多信息
与本研究相关的术语
其他研究编号
- POPEYE
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