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临床试验/NCT02441621
NCT02441621Unknown不适用

Prediction of Fluid Responsiveness in Presence of Diastolic Dysfunction

University Hospital Schleswig-Holstein2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Increase in stroke volume index (SVI) >15%

研究概览

简要总结

The ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV) and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of left ventricular diastolic dysfunction is still unknown. The aim of the present study was to challenge the predictive power of GEDVI, SVV and PPV in cardiac surgery patients undergoing aortic valve replacement.

详细描述

All patients receive premedication with midazolam 7.5 mg p.o.. After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O. Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter and a central venous catheter in the right or left internal jugular vein. Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction. In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany). Additionally capnography, urine output, temperature (blood, bladder and nasopharyngeal), airway pressure, and pulse oximetry are recorded.

Before starting operation a passive leg raising is performed. The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and was performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size. In case of an increase of stroke volume index (SVI) >15% during PLR, patients were defined as responders.

All patients were studied with no changes in anesthesia management. Measurements of SVI, GEDVI, SVV and PPV are performed before, during and after PLR. Thereafter, patients receive a fluid Bolus of 500 ml crystalloids. Again, measurements are performed before and after fluid replacement.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 yrs of age
  • Patients with a left ventricular ejection fraction ≥0.5
  • Patients with left ventricular diastolic dysfunction.

排除标准

  • Emergency procedures
  • Right ventricular dysfunction
  • Hemodynamic instability requiring pharmacologic Support
  • Ongoing arrhythmia
  • Intracardiac Shunts
  • Severe mitral stenosis or insufficiency
  • Aortic aneurysm > 4 cm
  • Use of an artificial left ventricular assist device or intra - aortic balloon pump.

结局指标

主要结局

Increase in stroke volume index (SVI) >15%

时间窗: Patients will be obtained until the end of the operation, an expected average of 5 hours

In presence of an increase of SVI \>15% during PLR and/or 500 ml crystalloids, patients are defined as responders.

次要结局

未报告次要终点

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ole Broch, MD

MD

University Hospital Schleswig-Holstein

研究点 (2)

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