NCT02291276撤回不适用
Perioperative Assessment of Right Ventricular Function and Venous Return in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery (GynRight) - Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Venous return
研究概览
简要总结
In this prospective, observational study the investigators assess the perioperative course of right ventricular function in combination with the venous return in patients undergoing major non-cardiac surgery. The study aims to investigate if patients undergoing major non-cardiac surgery develop an impairment of right ventricular function and/or venous return. Furthermore, the study evaluates if an impairment of right ventricular function and/or venous return is associated to left ventricular function, arterial side of the circulation and to postoperative clinical outcome.
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
- 否
入选标准
- •Offered patient information and written informed consent
- •Female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour
- •Patient Group 1: Female patients with > 500 ml ascites in the preoperative sonographic examination
- •Patient group 2: Female patients aged > 70 years and at least one of the following secondary diagnoses:
- •Status Post stent placement due to coronary heart disease respectively Status Post-myocardial infarction
- •existing arterial Hypertension for more than 5 years
- •chronic heart failure (New York Heart Association (NYHA) class II-III)
- •peripheral arterial disease
排除标准
- •Patients aged less than 18 years
- •Persons without the capacity to consent
- •Inability 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 at the beginning of hospitalization
- •Operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study
- •Neurological or psychiatric disease at the beginning of hospitalization
- •CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalization
- •American Society of Anesthesiologists (ASA) classification greater than IV
- •Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalization
- •Pulmonary oedema in thorax x-ray at the beginning of hospitalization
- •History of intracranial hemorrhage within one year before participation in the study
- •Conditions following venous thrombosis within the last three years before study inclusion
- •Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions
- •Diabetes mellitus with signs of severe neuropathy
- •Known atrial fibrillation
- •Participation in an interventional clinical trial during the study period; exception: assignment to adjuvant therapy study during this study is allowed.
结局指标
主要结局
Venous return
时间窗: Up to the first postoperative day
Venous return will be assessed perioperatively by venous return pressure gradient (dVR)
Right ventricular function
时间窗: Up to the first postoperative day
Right ventricular function will be measured perioperatively by a combination of right ventricular stroke volume, tricuspid annular plane systolic excursion (TAPSE), hepatic venous blood flow, variations in diameter of vena cavae, and right ventricle/left ventricle-ratio.
次要结局
- Venous return variables according to Guyton concept(Up to the first postoperative day)
- Organ complications(Participants will be followed up until hospital discharge, an average of two weeks)
- Immunological parameter(Up to the third postoperative day)
- Endothelial parameter(Up to the third postoperative day)
- Microvascular function(Up to the first postoperative day)
- Functional status(Baseline and hospital discharge with an expected average stay of 14 days)
- Hospital length of stay(Participants will be followed up until hospital discharge, an average of two weeks)
- Variables of transthoracic and transesophageal echocardiography(Up to the first postoperative day)
- Postoperative pain(Up to the third postoperative day)
- Hemodynamic variables(Up to the third postoperative day)
- Catecholamine administration(Up to the third postoperative day)
- Blood loss(Up to the third postoperative day)
- Fluid balance(Up to the third postoperative day)
- Quality of life(Baseline and hospital discharge with an expected average of 14 days)
- Intensive care unit length of stay(Participants will be followed up until intensive crae unit discharge, an average of two days)
研究者
Claudia Spies
Univ.- Prof. Dr. Claudia Spies
Charite University, Berlin, Germany
研究点 (1)
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