Prediction of Volume Responsiveness After Propofol Bolus Injection in the Intensive Care Unit (ICU) Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximum left ventricular contractility (dPmax)
研究概览
简要总结
Patients in ICU who suffer from circulatory insufficiency, regardless the cause that require invasive hemodynamic monitoring. The aim of the study is to correlate stroke volume variation which predicts fluid responsiveness with change of the blood pressure after intravenous admission of propofol. This test could become a surrogate of stroke volume variation in patients with contraindications to minimally invasive hemodynamic monitoring.
详细描述
This prospective, observational study was conducted after approval of the Independent Bioethics Commitee at Medical University of Gdańsk (numer zgody) and registered in ClinicalTrials.gov. Mechanically ventilated patients of intensive care unit who routinely recieved haemodynamic monitoring with PiCCO™ (Getinge AB, Sweden) technology using Philips IntelliVue PiCCO-Module (Philips Healthcare, Amsterdam, Netherlands), were enrolled. Patients were sedated with midazolam infusion at 0,15 to 0,6 mg kg-1 h-1 . Before the trial in each patient, heart rate (HR) invasive (IBP) and non - invasive blood pressure, (NIBP) infusion rate of catecholamines and non adrenergic vasopressors was recorded and PiCCO device was callibrated by transpulmonary thermodilution with 20 ml of cold saline. Global end diastolic volume (GEDV), intrathoracic blood volume (ITBV) and stroke volume variation (SVV) were calculated and recorded. For effective ventilation with increased tidal volume of 8 ml kg-1 of Predicted Body Weight, each patient recieved propofol bolus of 0,25 mg kg-1, 0,5 mg kg-1 and 1,0 mg kg-1 consecutively. Higher doses were used at good tolerance of the lower ones. After each bolus systolic and diastolic invasive blood pressure, heart rate (HR), continuous cardiac output (CCO), continuous cardiac index (CCI), stroke volume index (SI), stroke volume variantion (SVV), and left ventricular contractility index (dPmax) were recorded every fifteen seconds for ten minutes. The absolute and realtive change in blood pressure, compared to the values of blood pressure before the drug administration, were correlated with SVV. Time interval between each examination ranged from 4 to 48 hours.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patient Haemodynamically instable Mechanically ventilated
排除标准
- •Simultaneous propofol infusion Contraindications for propofol Atrial fibrillation Valvular malfunction Aortic stenosis Aortic aneurysm
研究组 & 干预措施
Euvolaemic
Patients with stroke volume variation less than 8%
干预措施: Propofol bolus (Drug)
Hypovolaemic
Patients with stroke volume variation greater than 13%
干预措施: Propofol bolus (Drug)
结局指标
主要结局
Maximum left ventricular contractility (dPmax)
时间窗: 10 minutes
Change in dPmax values after propofol bolus.
Cardiac output
时间窗: 10 minutes
Change in cardiac output values after propofol bolus.
Blood pressure
时间窗: 10 minutes
Change in blood pressure values after propofol bolus.
Heart rate
时间窗: 10 minutes
Change in heart rate values after propofol bolus.
Cardiac index
时间窗: 10 minutes
Change in cardiac index values after propofol bolus.
Stroke volume
时间窗: 10 minutes
Change in stroke volume values after propofol bolus.
Stroke index
时间窗: 10 minutes
Change in stroke index values after propofol bolus.
Stroke volume variation
时间窗: 10 minutes
Change in stroke volume variation values after propofol bolus.
次要结局
未报告次要终点
研究者
Radosław Owczuk
Professor
Medical University of Gdansk
