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临床试验/NCT03917446
NCT03917446已完成不适用

Prediction of Volume Responsiveness After Propofol Bolus Injection in the Intensive Care Unit (ICU) Patients.

Medical University of Gdansk1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Radosław Owczuk

Professor

Medical University of Gdansk

研究点 (1)

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