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临床试验/NCT03534440
NCT03534440已完成不适用

Assessment of Left Ventricle Diastolic Function in High Risk Patients Undergoing Major Vascular Surgery as an Early Indicator of Cardiac Failure. Observational Study

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Change in left ventricle diastolic function in time

研究概览

简要总结

Patients scheduled for Thoracic Endovascular Aortic Repair (TEVAR) surgery will have transthoracic echocardiography evaluation of left ventricle diastolic function during the perioperative period.

详细描述

Patients undergoing TEVAR surgery are a high risk group of developing perioperative cardiovascular complications.

Left ventricle diastolic dysfunction is common in this group of patients because of the prevalence of risk factors: > 60 years old, hypertension, smoking history and diabetes.

Because of many predisposing factors that occur during the surgery: stress respond, fluid shifts, anaesthesia and mechanical ventilation. Deterioration of the diastolic function is likely to occur in perioperative period

In this study, the investigators will evaluate change in left ventricle diastolic function as a marker for early detection of a myocardial failure in patients scheduled for an elective TEVAR surgery. The examination will be performed preoperatively, shortly after the surgery and 24 hours after the surgery.

Aim: The aim of the study is to evaluate the diastolic function of left ventricle in perioperative period after high risk surgery. This may provide a valuable information in preoperative risk stratification and postoperative therapy guidance.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled TEVAR
  • >60 years old

排除标准

  • Atrial fibrillation or other non-sinus rhythms
  • Atrioventricular blocks
  • Heart rate change more than 25% postoperatively
  • Not adequate transthoracic view
  • Postoperative shock

结局指标

主要结局

Change in left ventricle diastolic function in time

时间窗: Baseline, 2 hours and 24 hours

Echocardiographic assessment of change in left ventricle diastolic function repeated in time intervals: Baseline before the surgery, 2 and 24 hours after the surgery

次要结局

  • Change in biochemistry markers: troponins(Baseline, 2 hours and 24 hours)
  • Length of stay in hospital(up to 14 days)
  • Change in left ventricle systolic function(Baseline, 2 hours and 24 hours)
  • Kidney function(72 hours)
  • Fluid balance(72 hours)
  • Change in biochemistry markers: brain natriuretic peptide(Baseline, 2 hours and 24 hours)
  • Hemodynamic parameters: Heart rate(Baseline, 2 hours and 24 hours)
  • Hemodynamic parameters: Systolic and diastolic pressure(Baseline, 2 hours and 24 hours)
  • Mortality(up to 30 days)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mateusz Zawadka

Principal Investigator

Medical University of Warsaw

研究点 (1)

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