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临床试验/NCT02903316
NCT02903316已完成不适用

Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles and Investigation of a Novel Mini Fluid Challenge Ability to Predict Fluid Responsiveness

University of Aarhus1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
1
主要终点
Cardiac output changes

研究概览

简要总结

The purpose of this study is to determine if extra systoles can be used to predict fluid responsiveness perioperatively in patients undergoing on pump coronary artery bypass graft (CABG) surgery. As an additional study we will investigate the ability of a mini fluid challenge to predict response of a larger volume of fluid.

详细描述

From induction of anaesthesia to cardioplegia we will serve two fluid challenges. Before and after each challenge we will collect hemodynamic data and use this to asses our two hypotheses.

Fluid responsiveness (the outcome to predict) will be defined as a 15% increase in stroke volume(SV) from immediately before fluid infusion is initiated (baseline) to after the full fluid infusion. Stroke volume is derived from the gold-standard pulmonary artery catheter measurement of cardiac output(CO), which is standard monitoring for these patients (SV = CO/heart rate). From subsequent offline analysis of the extracted curve data we will investigate if post-ectopic characteristics from identified extra systoles during the baseline period can predict fluid responsiveness (i.e. the SV change). This analysis addresses the primary hypothesis. Also, we will analyse the arterial waveform related to the mini fluid challenge for morphologic changes (comparing heart beats before the infusion with heart beats during the infusion) and see if such transient changes, e.g. in systolic blood pressure, are able to predict fluid responsiveness. This analysis addresses the secondary hypothesis.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Predominant sinus rhythm (No atrial fibrillation, trigemini, 2nd and 3rd degree atrioventricular block also if pacing is present etc.)

排除标准

  • Ejection fraction < 35% (Safety limit minimising risk of fluid overload)
  • Haemodialysis (safety precaution for patients with end-stage kidney failure)
  • Pregnancy
  • Mentally retarded (due to lack of capability to sign an informed consent)

结局指标

主要结局

Cardiac output changes

时间窗: At 5 minutes

From initiation of fluid infusion

Systolic arterial pressure changes

时间窗: 10 minutes prior to fluid infusion

In relation to extra systoles

次要结局

  • Arterial waveform changes(10 seconds)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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