NCT01311297终止不适用
Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course - a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Filtration coefficient
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Filtration coefficient
时间窗: up to one hour single measurement in pregnant woman
Endothelial parameter from the examination with venous occlusion plethysmography.
次要结局
- All patients: Endothelial flow-mediated vasodilatation(perioperatively up to the fifth postoperative day in patients undergoing surgery)
- Perioperative patients: Blood loss(perioperatively up to the fifth postoperative day in patients undergoing surgery)
- Perioperative patients: Incidence and impact of organ dysfunctions(perioperatively up to the fifth postoperative day in patients undergoing surgery)
- Perioperative patients: Pain(perioperatively up to the fifth postoperative day in patients undergoing surgery)
- Perioperative patients: Body weight(perioperatively up to the fifth postoperative day in patients undergoing surgery)
- Perioperative patients: Satisfaction of the patients, surgeon and anesthesiologist(on the day of surgery)
- Perioperative patients: Duration until clinical discharge criteria were satisfied(perioperatively up to the fifth postoperative day in patients undergoing surgery)
- Perioperative patients: Intensive care unit average length of stay; hospital average length of stay(perioperatively up to the fifth postoperative day in patients undergoing surgery)
- Perioperative patients: Quality of life(perioperatively up to hospital discharge in patients undergoing surgery, an expexcted average of two weeks)
- Perioperative patients: Parameter of monitored sedation (BIS - Monitoring)(during the operation)
- All patients: Immunological Markers(perioperatively up to the fifth postoperative day in patients undergoing surgery)
- All patients: Hemodynamic parameters(perioperatively up to the fifth postoperative day in patients undergoing surgery)
- All patients: Markers of endothelial dysfunction (ICAM-1, E-Selectin, vWF)(perioperatively up to the fifth postoperative day in patients undergoing surgery)
- Pregnant patients: History data of the pregnancy, parameter of Gestosis(up to one hour single measurement in pregnant woman)
研究者
Claudia Spies
Prof. , MD Director of the Department of Anaesthesiology and Intensive Care Medicine CVK/CCM
Charite University, Berlin, Germany
研究点 (1)
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